Cleared Traditional

K842573 - T.P.G. CAST TAPE (FDA 510(k) Clearance)

Aug 1984
Decision
38d
Days
Class 1
Risk

K842573 is an FDA 510(k) clearance for the T.P.G. CAST TAPE. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).

Submitted by The Poly Group, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984, 38 days after receiving the submission on July 3, 1984.

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

Submission Details

510(k) Number K842573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date August 10, 1984
Days to Decision 38 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