Cleared Traditional

NON - ADHERENT BANDAGE (K833733) - FDA 510(k) Clearance

K833733 · American Medical Disposable, Inc. · General & Plastic Surgery device

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Dec 1983

Decision

63d

Days

Risk

K833733 is an FDA 510(k) clearance for the NON - ADHERENT BANDAGE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Medical Disposable, Inc. (Walker, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Disposable, Inc. devices

Submission Details

510(k) Number	K833733 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 25, 1983
Decision Date	December 27, 1983
Days to Decision	63 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

52d faster than avg

Panel avg: 115d · This submission: 63d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

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Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833733

American Medical Disposable, Inc.

Walker, MI · US

Regulatory profile

33 submissions 33 cleared

100% clearance rate · Active in General & Plastic Surgery

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Sourced from FDA 510(k) public files . Updated monthly.

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