PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS— 510(k) K873097

Name: FDA 510(k) clearance K873097
Creator: U.S. Food and Drug Administration
Published: 1987-09-04

Substantially Equivalent

Ipax, Inc.

FDA 510(k) clearance K873097 for PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS, Substantially Equivalent on 1987-09-04. Applicant: Ipax, Inc.. Device class: 1.

Clearance details

Applicant: Ipax, Inc.
Product code: Code GBQ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1987-07-27
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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