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510(k) K862219

T.P.N. DRESSING CHANGE TRAY by Welmed Systems, Inc.

K862219 is an FDA 510(k) premarket notification submitted by Welmed Systems, Inc. for the device "T.P.N. DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent (with conditions) on July 8, 1986. Welmed Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
July 8, 1986
Date Received
June 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Welmed Systems, Inc.

  • K863282 — CARE + PLUS CATHETER CARE TRAY (October 31, 1986)
  • K863281 — CARE + PLUS IRREGATION TRAY (October 31, 1986)
  • K863497 — SUCTION CATHETER KIT (October 6, 1986)
  • K863284 — I.V. START KIT (September 22, 1986)
  • K863283 — CARE + PLUS SUTURE REMOVAL TRAY (September 15, 1986)
  • K862663 — TRACHEOSTOMY CARE TRAY (July 30, 1986)

FDA data resources