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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Irrigation
510(k) Number K921464
Device Name CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT
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 Number878.4200
Classification Product Code
GBQ  
Date Received03/27/1992
Decision Date 05/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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