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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K990091
Device Name S.P.A.R STERILE AMBULATORY RESERVOIR
Applicant
Faulding Pharmaceutical Co.
11 Commerce Dr.
Cranford,  NJ  07016
Applicant Contact HEIKE MAASER
Correspondent
Faulding Pharmaceutical Co.
11 Commerce Dr.
Cranford,  NJ  07016
Correspondent Contact HEIKE MAASER
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received01/11/1999
Decision Date 04/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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