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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K952058
Device Name STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
Applicant
Trinity Laboratories, Inc.
201 Kiley Dr.
P.O. Box 1818
Salisbury,  MD  21802
Applicant Contact PARTHA BASUMALLIK
Correspondent
Trinity Laboratories, Inc.
201 Kiley Dr.
P.O. Box 1818
Salisbury,  MD  21802
Correspondent Contact PARTHA BASUMALLIK
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/02/1995
Decision Date 09/21/1995
Decision Substantially Equivalent (SESE)
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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