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510(k) K823399

COVER LIMB by Orthopedic Systems, Inc. — Product Code IPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
November 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Limb
Device Class
Class I
Regulation Number
890.3025
Review Panel
PM
Submission Type

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Other clearances for product code IPM

  • K872488 — ELASTO-GEL CAST & SPLINT PADS (September 21, 1987)
  • K801627 — COVER, LIMB (July 28, 1980)
  • K780905 — LIMB COVER (August 14, 1978)
  • K770223 — HEAVY FOAM HEEL & ELBOW PROTECTORS (February 23, 1977)
  • K761114 — FOAM SLIPPERS (December 2, 1976)