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510(k) Data Aggregation
K Number
K990091Device Name
S.P.A.R STERILE AMBULATORY RESERVOIR
Manufacturer
Date Cleared
1999-04-04
(83 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
FAULDING PHARMACEUTICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The S.P.A.R. " Sterile Ambulatory Reservoir is intended for use with the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 Ambulatory Infusion Pumps, manufactured and distributed by Sims Deltec Inc., St. Paul, Minnesota. The S.P.A.R. Ambulatory Reservoir is intended for use as an accessory to the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps by replacing the Deltec Medication Cassette ™, Model 2050 - 50 mL and 2100 - 100 mL with S.P.A.R. ™ Sterile Ambulatory Reservoir.
Device Description
The S.P.A.R.TM Sterile Ambulatory Reservoir is a sterile, disposable, nonpyrogenic, tamper proof (evident), ambulatory, reservoir system designed for use with the SIMS Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps.
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