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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K852442
Device Name PHARMA-PLAST NEEDLE
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 Number880.5570
Classification Product Code
FMI  
Date Received06/10/1985
Decision Date 09/20/1985
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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