REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG— 510(k) K935975

Name: FDA 510(k) clearance K935975
Creator: U.S. Food and Drug Administration
Published: 1994-09-19

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K935975 for REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG, Substantially Equivalent on 1994-09-19. Applicant: Remel, Inc.. Device class: 2.

Clearance details

Applicant: Remel, Inc.
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 1993-12-13
Decision date: 1994-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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