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510(k) K810228

SORBOTHANE by Hamilton Kent — Product Code KNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1981
Date Received
January 27, 1981
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 for product code KNP

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  • K823654 — SLIP-ON SANDALS FOR MEASURING SHORTNESS (January 21, 1983)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K801743 — PLASTAZOTE SHOE (August 7, 1980)
  • K790326 — DRUSHOE (February 26, 1979)