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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K974286
Device Name CIRCUMCISION TRAY, CAT. NO. 70340
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 Number884.4530
Classification Product Code
HFX  
Date Received11/14/1997
Decision Date 12/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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