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510(k) Clearances
/ K863284
510(k) K863284
I.V. START KIT by
Welmed Systems, Inc.
Clearance Details
Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
September 22, 1986
Date Received
August 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
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K863497
— SUCTION CATHETER KIT (October 6, 1986)
K863283
— CARE + PLUS SUTURE REMOVAL TRAY (September 15, 1986)
K862663
— TRACHEOSTOMY CARE TRAY (July 30, 1986)
K862219
— T.P.N. DRESSING CHANGE TRAY (July 8, 1986)