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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K951506
Device Name SUCTION CATHETER KIT, STERILE, SINGLE-USE
Applicant
TRINITY LABORATORIES, INC.
201 KILEY DR.
P.O. BOX 1818
SALISBURY,  MD  21802
Applicant Contact PARTHA BASUMALLIK
Correspondent
TRINITY LABORATORIES, INC.
201 KILEY DR.
P.O. BOX 1818
SALISBURY,  MD  21802
Correspondent Contact PARTHA BASUMALLIK
Regulation Number868.6810
Classification Product Code
BSY  
Date Received04/03/1995
Decision Date 07/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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