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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K902307
Device Name SHAW II HEMOSTATIC SURGERY SYSTEM
Applicant
Hemostatic Surgery Corp.
Four Embarcadero Center, Suite
3320
San Francisco,  CA  94111
Applicant Contact PHILIP E EGGERS
Correspondent
Hemostatic Surgery Corp.
Four Embarcadero Center, Suite
3320
San Francisco,  CA  94111
Correspondent Contact PHILIP E EGGERS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/22/1990
Decision Date 08/17/1990
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
Recalls CDRH Recalls
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