BX-200 SC— 510(k) K943185

Substantially Equivalent for Some Indications

Bloomex International, Inc.

FDA 510(k) clearance K943185 for BX-200 SC, Substantially Equivalent for Some Indications on 1995-08-14. Applicant: Bloomex International, Inc..

Clearance details

Applicant: Bloomex International, Inc.
Product code: Code IPF
Advisory panel: Physical Medicine
Date received: 1994-04-12
Decision date: 1995-08-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Elmwood Park, NJ, US

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