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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
Applicant Contact MARK STERRETT
Correspondent
Louisville Laboratories, Inc.
2400 Crittenden Dr.
Louisville,  KY  40217
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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