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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 K980123
Device Name CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
Applicant
Louisville Laboratories, Inc.
2400 Crittenden Dr.
Louisville,  KY  40217 -1865
Applicant Contact MARK STERRETT
Correspondent
Louisville Laboratories, Inc.
2400 Crittenden Dr.
Louisville,  KY  40217 -1865
Correspondent Contact MARK STERRETT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/14/1998
Decision Date 03/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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