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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K873588
Device Name 10CC CONTROL SYRINGE
Applicant
Medi-Plast Intl., Inc.
1050 Northfield Court
Suite 300
Roswell,  GA  30076
Applicant Contact KATHLEEN A LUMBERG
Correspondent
Medi-Plast Intl., Inc.
1050 Northfield Court
Suite 300
Roswell,  GA  30076
Correspondent Contact KATHLEEN A LUMBERG
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/04/1987
Decision Date 10/23/1987
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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