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510(k) K872488

ELASTO-GEL CAST & SPLINT PADS by Southwest Technologies, Inc. — Product Code IPM

K872488 is an FDA 510(k) premarket notification submitted by Southwest Technologies, Inc. for the device "ELASTO-GEL CAST & SPLINT PADS". The FDA issued a decision of SN on September 21, 1987. The device falls under product code IPM (Cover, Limb), a Class I device regulated under 21 CFR 890.3025. Southwest Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 21, 1987
Date Received
June 23, 1987
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 Southwest Technologies, Inc.

  • K102478 — OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING (November 3, 2010)
  • K083334 — ELASTO-GEL MANUKA HONEY WOUND DRESSING (July 30, 2009)
  • K030774 — STIMULEN COLLAGEN (August 9, 2004)
  • K872165 — ELASTO-GEL OCCLUSIVE DRESSING (June 26, 1987)

Other clearances for product code IPM

  • K823399 — COVER LIMB (November 29, 1982)
  • 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)

FDA data resources