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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K895290
Device Name CHEMO-SPIKE RECONSTITUTION DEVICE
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 Number880.5440
Classification Product Code
FPA  
Date Received08/25/1989
Decision Date 12/27/1989
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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