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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrosurgical
510(k) Number K913300
Device Name LAPAROSTAT(TM)
Applicant
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number878.4400
Classification Product Code
HAM  
Date Received07/25/1991
Decision Date 04/02/1992
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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