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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dermatome
510(k) Number K862669
Device Name ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
Applicant
U. S. Diagnostics, Inc.
P.O. Box 4522
3443 Miguelito Ct.
San Luis Obispo,  CA  93401
Applicant Contact ROY E SPECK
Correspondent
U. S. Diagnostics, Inc.
P.O. Box 4522
3443 Miguelito Ct.
San Luis Obispo,  CA  93401
Correspondent Contact ROY E SPECK
Regulation Number878.4820
Classification Product Code
GFD  
Date Received07/14/1986
Decision Date 10/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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