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510(k) K801627

COVER, LIMB by The Owenby Co. — Product Code IPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
July 15, 1980
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

Other clearances by The Owenby Co.

  • K801628 — RESTRAINT, PROTECTIVE (August 7, 1980)
  • K801626 — ARM SLING (July 28, 1980)
  • K801532 — STOCKINETTE, STERILE TWO PLY W/PULL TABS (July 28, 1980)
  • K801531 — ARM SLING (July 21, 1980)
  • K790210 — STOCKINETTE, TUBULAR UNBLEACHED (February 27, 1979)
  • K780764 — NON-STERILE FOLDED GAUZE (June 6, 1978)
  • K780418 — BURN DRESSING PAD (April 10, 1978)
  • K770889 — BURN DRESSING KIT (July 11, 1977)
  • K761071 — P.S.M. JUSTA KAP (December 30, 1976)
  • K761069 — P.S.M. BOTIQUE CAP (December 30, 1976)

Other clearances for product code IPM

  • K872488 — ELASTO-GEL CAST & SPLINT PADS (September 21, 1987)
  • K823399 — COVER LIMB (November 29, 1982)
  • K780905 — LIMB COVER (August 14, 1978)
  • K770223 — HEAVY FOAM HEEL & ELBOW PROTECTORS (February 23, 1977)
  • K761114 — FOAM SLIPPERS (December 2, 1976)