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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ultrasonic surgical
510(K) Number K121550
Models HAR23, HAR36, HC325
Device Name HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY
Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati,  OH  45242
Contact marcia aretz
Classification Product Code
LFL  
Date Received05/25/2012
Decision Date 08/22/2012
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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