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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 K934750
Device Name YANKAUER WITH CONNECTING TUBING
Applicant
TRINITY LABORATORIES, INC.
201 KILEY DR.
SALISBURY,  MD  21801
Applicant Contact PARTHA BASUMALLIK
Correspondent
TRINITY LABORATORIES, INC.
201 KILEY DR.
SALISBURY,  MD  21801
Correspondent Contact PARTHA BASUMALLIK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/04/1993
Decision Date 02/17/1994
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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