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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 K941897
Device Name ULTRACISON HARMONIC SCALPEL HS2 BLADE
Applicant
Ultracision, Inc.
25 Thurber Blvd.
Smithfield,  RI  02917
Applicant Contact JOHN C WRIGHT
Correspondent
Ultracision, Inc.
25 Thurber Blvd.
Smithfield,  RI  02917
Correspondent Contact JOHN C WRIGHT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/18/1994
Decision Date 07/01/1994
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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