P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL— 510(k) K863950

Name: FDA 510(k) clearance K863950
Creator: U.S. Food and Drug Administration
Published: 1986-10-24

Substantially Equivalent

Precision Surgical Industries, Inc.

FDA 510(k) clearance K863950 for P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL, Substantially Equivalent on 1986-10-24. Applicant: Precision Surgical Industries, Inc.. Device class: 1.

Clearance details

Applicant: Precision Surgical Industries, Inc.
Product code: Code GDX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-10-10
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scotch Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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