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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 K895419
Device Name DISPOSABLE DISC FILTER
Applicant
The Medi-Dose Group
1671 Loretta Ave.
Feasterville,  PA  19047
Applicant Contact MILTON BRAVERMAN
Correspondent
The Medi-Dose Group
1671 Loretta Ave.
Feasterville,  PA  19047
Correspondent Contact MILTON BRAVERMAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/01/1989
Decision Date 11/24/1989
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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