Home / 510(k) Clearances / K822577

510(k) K822577

OPERAND SUTURE REMOVAL TRAY by Medcare Products

K822577 is an FDA 510(k) premarket notification submitted by Medcare Products for the device "OPERAND SUTURE REMOVAL TRAY". The FDA issued a decision of Substantially Equivalent on October 22, 1982. Medcare Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1982
Date Received
August 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Medcare Products

  • K841122 — TRACHEOSTOMY CARE TRAY (April 25, 1984)
  • K841124 — DIALYSIS TRAY (April 20, 1984)
  • K841123 — DRESSING CHANGE TRAY (April 17, 1984)
  • K831374 — MED CARE PREP RAZOR (October 4, 1983)
  • K831663 — TISSUE FORCEPS (September 26, 1983)
  • K831665 — DISPOSABLE NEEDLE HOLDER (September 12, 1983)
  • K831664 — PLASTIC THUMB FORCEPS (September 12, 1983)
  • K831661 — DISPOSABLE SCISSORS (August 25, 1983)
  • K831662 — DISPOSABLE HEMOSTAT (STRAIGHT&CURVED (July 19, 1983)
  • K823854 — MEDCARE SUTURE REMOVAL TRAYS (March 31, 1983)

FDA data resources