STAPLE INSERTER-EXTRACTOR FOR ARTHROS— 510(k) K830456

Name: FDA 510(k) clearance K830456
Creator: U.S. Food and Drug Administration
Published: 1983-03-09

Substantially Equivalent

Instrument Makar, Inc.

FDA 510(k) clearance K830456 for STAPLE INSERTER-EXTRACTOR FOR ARTHROS, Substantially Equivalent on 1983-03-09. Applicant: Instrument Makar, Inc.. Device class: 1.

Clearance details

Applicant: Instrument Makar, Inc.
Product code: Code HXJ
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1983-02-09
Decision date: 1983-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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