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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 K952726
Device Name ULTRACISION HARMONIC SCAPEL
Applicant
Ultracision, Inc.
25 Thurber Blvd.
Smithfield,  RI  02917
Applicant Contact JOHN WRIGHT
Correspondent
Ultracision, Inc.
25 Thurber Blvd.
Smithfield,  RI  02917
Correspondent Contact JOHN WRIGHT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/14/1995
Decision Date 06/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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