Cleared Traditional

45 DEGREE SHAVER

K870882 · Bowen & Company, Inc. · General & Plastic Surgery
Mar 1987
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K870882 is an FDA 510(k) clearance for the 45 DEGREE SHAVER, a Instrument, Cutting, Orthopedic (Class I — General Controls, product code HTZ), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on March 23, 1987, 18 days after receiving the submission on March 5, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K870882 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1987
Decision Date March 23, 1987
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HTZ — Instrument, Cutting, Orthopedic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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