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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 K870995
Device Name SCALP VEIN SET
Applicant
Mac Lee Medical Products
2900 SW Atwood
Topeka,  KS  66614
Applicant Contact GEORGE E LIESMANN
Correspondent
Mac Lee Medical Products
2900 SW Atwood
Topeka,  KS  66614
Correspondent Contact GEORGE E LIESMANN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/11/1987
Decision Date 07/31/1987
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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