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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K920282
Device Name PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
Applicant
Trinity Laboratories, Inc.
P.O. Box 4458
201 Kiley Dr.
Salisbury,  MD  21803
Applicant Contact PARTHA BASUMALLIK
Correspondent
Trinity Laboratories, Inc.
P.O. Box 4458
201 Kiley Dr.
Salisbury,  MD  21803
Correspondent Contact PARTHA BASUMALLIK
Regulation Number878.4014
Classification Product Code
NAB  
Date Received01/22/1992
Decision Date 05/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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