Cleared Traditional

BIOPSY TRAY

K970152 · Medcare Medical Group, Inc. · General Hospital
Mar 1997
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K970152 is an FDA 510(k) clearance for the BIOPSY TRAY, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on March 5, 1997, 48 days after receiving the submission on January 16, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K970152 FDA.gov
FDA Decision Cleared SN
Date Received January 16, 1997
Decision Date March 05, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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