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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 K883311
Device Name COUNT-A-DOSE
Applicant
Pavel Jordan & Associates, Inc.
3001 Chapel Hill Rd.
Orange,  CA  92667
Applicant Contact WILLIE KRAWITZ
Correspondent
Pavel Jordan & Associates, Inc.
3001 Chapel Hill Rd.
Orange,  CA  92667
Correspondent Contact WILLIE KRAWITZ
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/05/1988
Decision Date 09/15/1988
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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