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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Insulin
510(k) Number K884978
Device Name PHARMA-PLAST INSULIN INFUSION SET
Applicant
Pharma-Plast USA, Inc.
1801 Mcgill College Ave.
Suite 1470, Montreal
Canada H3a 2n4,  CA
Applicant Contact DOUGLAS M BENNETT
Correspondent
Pharma-Plast USA, Inc.
1801 Mcgill College Ave.
Suite 1470, Montreal
Canada H3a 2n4,  CA
Correspondent Contact DOUGLAS M BENNETT
Regulation Number880.5725
Classification Product Code
LZG  
Date Received11/30/1988
Decision Date 06/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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