SWISSTEK 2000(TM) CAST REMOVAL SYSTEM— 510(k) K932653

Name: FDA 510(k) clearance K932653
Creator: U.S. Food and Drug Administration
Published: 1994-01-28

Substantially Equivalent

Carapace, Inc.

FDA 510(k) clearance K932653 for SWISSTEK 2000(TM) CAST REMOVAL SYSTEM, Substantially Equivalent on 1994-01-28. Applicant: Carapace, Inc.. Device class: 1.

Clearance details

Applicant: Carapace, Inc.
Product code: Code LGH
Device class: Class 1
Regulation: 21 CFR 888.5960
Advisory panel: Orthopedic
Date received: 1993-06-02
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broken Arrow, OK, US

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