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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K921490
Device Name DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
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 Number880.6850
Classification Product Code
FRG  
Date Received03/30/1992
Decision Date 10/05/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
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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