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510(k) K872121

K AND D HOME TRACT by Joseph A. Kott, M.D. — Product Code HST

K872121 is an FDA 510(k) premarket notification submitted by Joseph A. Kott, M.D. for the device "K AND D HOME TRACT". The FDA issued a decision of Substantially Equivalent on August 12, 1987. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1987
Date Received
May 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Traction, Non-Powered
Device Class
Class I
Regulation Number
888.5850
Review Panel
NE
Submission Type

Other clearances for product code HST

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  • K110858 — LO-BAK TRAX (August 2, 2011)
  • K984190 — BACK-ON-TRAC, MODEL 101BOT (March 15, 1999)
  • K870212 — ARTHROSCOPIC SHOULDER HOLDER (February 20, 1987)
  • K870125 — EXTREMITY ELEVATOR (February 4, 1987)
  • K870102 — TUPPER TROLLEY (February 3, 1987)
  • K864765 — MODEL 668, TRACTION SPLINT, ADULT (December 17, 1986)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)
  • K855179 — TRANSFER-TRAX (TM) SPLINT TRACTION (January 21, 1986)

FDA data resources