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510(k) K801627

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

K801627 is an FDA 510(k) premarket notification submitted by The Owenby Co. for the device "COVER, LIMB". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code IPM (Cover, Limb), a Class I device regulated under 21 CFR 890.3025. The Owenby Co. has at least 10 other 510(k) clearances on record.

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)
  • K761069 — P.S.M. BOTIQUE CAP (December 30, 1976)
  • K761070 — P.S.M. SURGICAL HOOD (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)

FDA data resources