Cleared Traditional

RITE-BITE BIOPSY FORCEPS

K951048 · Mill-Rose Laboratory · Gastroenterology & Urology
Mar 1995
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K951048 is an FDA 510(k) clearance for the RITE-BITE BIOPSY FORCEPS, a Forceps, Biopsy, Non-electric (Class I — General Controls, product code FCL), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on March 15, 1995, 9 days after receiving the submission on March 6, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K951048 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1995
Decision Date March 15, 1995
Days to Decision 9 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FCL — Forceps, Biopsy, Non-electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.1075

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