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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 K936015
Device Name DISPOSABLE DISC FILTER
Applicant
MEDI-DOSE, INC.
1671 LORETTA AVE.
FEASTERVILLE,  PA  19053
Applicant Contact MILTON BRAVERMAN
Correspondent
MEDI-DOSE, INC.
1671 LORETTA AVE.
FEASTERVILLE,  PA  19053
Correspondent Contact MILTON BRAVERMAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/16/1993
Decision Date 12/12/1994
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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