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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 K121426
Device Name AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
Applicant
SYNERGETICS, INC
3845 CORPORATE CENTRE DRIVE
O'FALLON,  MO  63368
Applicant Contact GARY OLIVEROS
Correspondent
SYNERGETICS, INC
3845 CORPORATE CENTRE DRIVE
O'FALLON,  MO  63368
Correspondent Contact GARY OLIVEROS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/14/2012
Decision Date 07/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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