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510(k) K780905

LIMB COVER by Hydro-Med Products, Inc. — Product Code IPM

K780905 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "LIMB COVER". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code IPM (Cover, Limb), a Class I device regulated under 21 CFR 890.3025. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 2, 1978
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 Hydro-Med Products, Inc.

  • K944198 — SURGICAL MICROSCOPE DRAPE (November 27, 1994)
  • K940151 — ULTRASOUND PROBE DRAPE (November 14, 1994)
  • K934630 — UNIVERSAL VIDEO/LASER ARM DRAPE (October 28, 1994)
  • K940152 — CAMERA COVER WITH TEAR TIP (October 28, 1994)
  • K923099 — X-RAY DRAPES (October 15, 1992)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K853281 — EASYTOP (August 21, 1985)
  • K842304 — THE PATHFINDER (August 1, 1984)
  • K834407 — STERILE DISPOSABLE SPINAL NEEDLES (March 19, 1984)
  • K812405 — STERILE TV CAMERA & CORD COVER (October 20, 1981)

Other clearances for product code IPM

  • K872488 — ELASTO-GEL CAST & SPLINT PADS (September 21, 1987)
  • K823399 — COVER LIMB (November 29, 1982)
  • K801627 — COVER, LIMB (July 28, 1980)
  • K770223 — HEAVY FOAM HEEL & ELBOW PROTECTORS (February 23, 1977)
  • K761114 — FOAM SLIPPERS (December 2, 1976)

FDA data resources