Cleared Traditional

K872624 - INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING (FDA 510(k) Clearance)

Jul 1987
Decision
23d
Days
Risk

K872624 is an FDA 510(k) clearance for the INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING. This device is classified as a Dressing, Wound, Drug.

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on July 29, 1987, 23 days after receiving the submission on July 6, 1987.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K872624 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 06, 1987
Decision Date July 29, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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