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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 K851516
Device Name CHERMEL SCALP VEIN SET
Applicant
Cher Mel Corp.
P.O. Box 68624
Seattle,  WA  98168
Applicant Contact CHERYL AMUNDSEN
Correspondent
Cher Mel Corp.
P.O. Box 68624
Seattle,  WA  98168
Correspondent Contact CHERYL AMUNDSEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/15/1985
Decision Date 08/23/1985
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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