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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 K080544
Device Name UNASSIGNED
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact JEAN CALLOW
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact JEAN CALLOW
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/27/2008
Decision Date 08/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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