Cleared Traditional

COMPRESSOGRIP TUBULAR ELASTIC BANDAGE

K831551 · Fred Sammons, Inc. · General Hospital
Jun 1983
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K831551 is an FDA 510(k) clearance for the COMPRESSOGRIP TUBULAR ELASTIC BANDAGE, a Bandage, Elastic (Class I — General Controls, product code FQM), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1983, 26 days after receiving the submission on May 12, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number K831551 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 07, 1983
Days to Decision 26 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FQM — Bandage, Elastic
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5075

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