SYSTEM U3 FOR GENTAMICIN— 510(k) K983252

Substantially Equivalent

Ab Biodisk North America, Inc.

FDA 510(k) clearance K983252 for SYSTEM U3 FOR GENTAMICIN, Substantially Equivalent on 1998-11-20. Applicant: Ab Biodisk North America, Inc..

Clearance details

Applicant: Ab Biodisk North America, Inc.
Product code: Code JWY
Advisory panel: Microbiology
Date received: 1998-09-16
Decision date: 1998-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

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