FORCEPS, SURGICAL GYNECOLOGICAL— 510(k) K944055

Name: FDA 510(k) clearance K944055
Creator: U.S. Food and Drug Administration
Published: 1994-09-20

Substantially Equivalent

Owens Precision Systems, Inc.

FDA 510(k) clearance K944055 for FORCEPS, SURGICAL GYNECOLOGICAL, Substantially Equivalent on 1994-09-20. Applicant: Owens Precision Systems, Inc.. Device class: 2.

Clearance details

Applicant: Owens Precision Systems, Inc.
Product code: Code HCZ
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1994-08-19
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Creek, WI, US

Download summary PDF View on FDA.gov ↗

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