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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 K000911
Device Name MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057
Applicant
Hysterx, Inc.
18732 Saginaw
Irvine,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
Hysterx, Inc.
18732 Saginaw
Irvine,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/21/2000
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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