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510(k) K823665

ROTATION BOOT by Warm & Form, Orthopedic Materials — Product Code KNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Corrective Shoe
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Warm & Form, Orthopedic Materials

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  • K830245 — HEAD HALTER (March 9, 1983)
  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K830246 — CAST SHOE, CAST BOOT (February 18, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823663 — ABDOMINAL BINDER (December 30, 1982)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823662 — RIB BELT (UNIVERSAL) (December 30, 1982)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823659 — PELVIC TRACTION BELT (December 30, 1982)

Other clearances for product code KNP

  • K831690 — IPOS ANTI-ADDUCTUS SHOE (June 24, 1983)
  • K831552 — SORBOTHANE VISCO INNER SOLE PAD (June 8, 1983)
  • K823654 — SLIP-ON SANDALS FOR MEASURING SHORTNESS (January 21, 1983)
  • K810228 — SORBOTHANE (February 10, 1981)
  • K801743 — PLASTAZOTE SHOE (August 7, 1980)
  • K790326 — DRUSHOE (February 26, 1979)