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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 K942414
Device Name TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773
Applicant Contact CAROL A WEIDEMAN
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773
Correspondent Contact CAROL A WEIDEMAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/20/1994
Decision Date 06/21/1994
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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