INTERMEDICS POWER BROACH IMPACTOR— 510(k) K895121

Name: FDA 510(k) clearance K895121
Creator: U.S. Food and Drug Administration
Published: 1989-09-11

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K895121 for INTERMEDICS POWER BROACH IMPACTOR, Substantially Equivalent on 1989-09-11. Applicant: Intermedics Orthopedics. Device class: 1.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1989-08-15
Decision date: 1989-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.