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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K920846
Device Name CENTRAL VENOUS CATHETER, DRESSING CHANGE KIT, STER
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 Number878.4040
Classification Product Code
FXX  
Date Received02/25/1992
Decision Date 09/01/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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