RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS— 510(k) K880074

Name: FDA 510(k) clearance K880074
Creator: U.S. Food and Drug Administration
Published: 1988-03-25

Substantially Equivalent

Romano Surgical Instrumentation, Inc.

FDA 510(k) clearance K880074 for RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS, Substantially Equivalent on 1988-03-25. Applicant: Romano Surgical Instrumentation, Inc.. Device class: 1.

Clearance details

Applicant: Romano Surgical Instrumentation, Inc.
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1988-01-11
Decision date: 1988-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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