S.P.A.R STERILE AMBULATORY RESERVOIR— 510(k) K990091

Name: FDA 510(k) clearance K990091
Creator: U.S. Food and Drug Administration
Published: 1999-04-04

Substantially Equivalent

Faulding Pharmaceutical Co.

FDA 510(k) clearance K990091 for S.P.A.R STERILE AMBULATORY RESERVOIR, Substantially Equivalent on 1999-04-04. Applicant: Faulding Pharmaceutical Co.. Device class: 2.

Clearance details

Applicant: Faulding Pharmaceutical Co.
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1999-01-11
Decision date: 1999-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranford, NJ, US

Download summary PDF View on FDA.gov ↗

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