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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 K984600
Device Name METRA PS PROCEDURE KIT
Applicant
INLET MEDICAL, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217
Applicant Contact MARK STERRETT
Correspondent
INLET MEDICAL, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217
Correspondent Contact MARK STERRETT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/28/1998
Decision Date 06/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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