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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
Contact gary oliveros
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/17/2012
Decision Date 07/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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