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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 K952242
Device Name TRANSFEER SPIKE II
Applicant
The Medi-Dose Group
1671 Loretta Ave.
Feasterville,  PA  19047
Applicant Contact ROBERT BRAVERMAN
Correspondent
The Medi-Dose Group
1671 Loretta Ave.
Feasterville,  PA  19047
Correspondent Contact ROBERT BRAVERMAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/12/1995
Decision Date 09/15/1995
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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