Cleared Traditional

K862803 - CHESEBROUGH POND'S HYDROCOLLOID DRESSING

K862803 · Chesebrough-Pond'S U.S.A. Co. · General & Plastic Surgery device
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Nov 1986
Decision
115d
Days
-
Risk

K862803 is an FDA 510(k) clearance for the CHESEBROUGH POND'S HYDROCOLLOID DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on November 14, 1986 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K862803 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 22, 1986
Decision Date November 14, 1986
Days to Decision 115 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 196
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K862803.
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
VISCOPASTE ZINC PASTE BANDAGE
K863930 · Smith & Nephew, Inc. · Dec 1986
HYDROCOLLOID DRESSINGS - STERILE
K863390 · Convatec, A Division of E.R. Squibb & Sons · Sep 1986
HOLLISTER WOUND CARE BARRIER
K862572 · Hollister, Inc. · Aug 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · Johnson & Johnson Professionals, Inc. · Jul 1986