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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K810627
Device Name MODEL 1301 BIOTAC (TM)
Applicant
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Applicant Contact Alfred A Iversen
Correspondent
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Correspondent Contact Alfred A Iversen
Regulation Number878.4800
Classification Product Code
GEA  
Date Received03/09/1981
Decision Date 04/02/1981
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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