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510(k) K801743

PLASTAZOTE SHOE by Alimed, Inc. — Product Code KNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
July 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Corrective Shoe
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Alimed, Inc.

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  • K963526 — STRAP WEDGE (October 28, 1996)
  • K920487 — MINI VIBRATOR (February 18, 1992)
  • K840156 — PROTECTA COAT SPONGES (March 23, 1984)
  • K822650 — SUPER DONUT (September 30, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K820516 — ARTERIAL CANALIZATION DEVICE (April 15, 1982)
  • K820517 — CONSTRUCTA FOAM (March 10, 1982)
  • K791189 — ECHO CARDIOGRAM PAD (July 17, 1979)

Other clearances for product code KNP

  • K831690 — IPOS ANTI-ADDUCTUS SHOE (June 24, 1983)
  • K831552 — SORBOTHANE VISCO INNER SOLE PAD (June 8, 1983)
  • K823654 — SLIP-ON SANDALS FOR MEASURING SHORTNESS (January 21, 1983)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K810228 — SORBOTHANE (February 10, 1981)
  • K790326 — DRUSHOE (February 26, 1979)