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510(k) K823662

RIB BELT (UNIVERSAL) by Warm & Form, Orthopedic Materials — Product Code IPX

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, Rib Fracture, Soft
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Warm & Form, Orthopedic Materials

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  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K830246 — CAST SHOE, CAST BOOT (February 18, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823663 — ABDOMINAL BINDER (December 30, 1982)

Other clearances for product code IPX

  • K823158 — RIB BELT (UNIVERSAL) (November 10, 1982)
  • K803239 — SOFTGOOD PRODUCTS AND SPLINTS (January 9, 1981)