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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 K122086
FOIA Releasable 510(k) K122086
Device Name THERMAL LIGATING SHEARS
Applicant
MICROLINE SURGICAL, INC
800 CUMMING CENTER
SUITE 166T
BEVERLY,  MA  01915
Applicant Contact WILLIAM MCCALLUM
Correspondent
MICROLINE SURGICAL, INC
800 CUMMING CENTER
SUITE 166T
BEVERLY,  MA  01915
Correspondent Contact WILLIAM MCCALLUM
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/16/2012
Decision Date 08/23/2012
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
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