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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K924281
Device Name HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY
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 Number876.1500
Classification Product Code
GCJ  
Date Received08/25/1992
Decision Date 04/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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