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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 K953410
Device Name BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR
Applicant
SPRINGFIELD SURGICAL INSTRUMENTS
MILL LN. RD.
BRIMFIELD,  MA  01010
Applicant Contact JAMY GANNOE
Correspondent
SPRINGFIELD SURGICAL INSTRUMENTS
MILL LN. RD.
BRIMFIELD,  MA  01010
Correspondent Contact JAMY GANNOE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/20/1995
Decision Date 09/29/1995
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
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