Cleared Traditional

K873111 - CONFORMA(TM) PLASTER BANDAGES (FDA 510(k) Clearance)

Oct 1987
Decision
60d
Days
Class 1
Risk

K873111 is an FDA 510(k) clearance for the CONFORMA(TM) PLASTER BANDAGES. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on October 9, 1987, 60 days after receiving the submission on August 10, 1987.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3025.

Submission Details

510(k) Number K873111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date October 09, 1987
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code ITG — Bandage, Cast
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3025