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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 K945953
Device Name GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)
Applicant
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Applicant Contact R L PRATT
Correspondent
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Correspondent Contact R L PRATT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/06/1994
Decision Date 03/03/1995
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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