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510(k) K863283

CARE + PLUS SUTURE REMOVAL TRAY by Welmed Systems, Inc.

K863283 is an FDA 510(k) premarket notification submitted by Welmed Systems, Inc. for the device "CARE + PLUS SUTURE REMOVAL TRAY". The FDA issued a decision of Substantially Equivalent on September 15, 1986. Welmed Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1986
Date Received
August 25, 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)
  • K862663 — TRACHEOSTOMY CARE TRAY (July 30, 1986)
  • K862219 — T.P.N. DRESSING CHANGE TRAY (July 8, 1986)

FDA data resources