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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 K946263
Device Name BRIMFIELD PRECISION GRASPER/DISSECTOR
Applicant
Springfield Surgical Instruments
Mill Ln. Rd.
Brimfield,  MA  01010
Applicant Contact JAMES GANNOE
Correspondent
Springfield Surgical Instruments
Mill Ln. Rd.
Brimfield,  MA  01010
Correspondent Contact JAMES GANNOE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/23/1994
Decision Date 01/26/1995
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
Predetermined Change
Control Plan Authorized		 No
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