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510(k) K972766

PIVOTING COMPENSATING FILTERS FOR THE HEAD by Octostop, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1997
Date Received
July 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Octostop, Inc.

  • K963941 — THE PHARAOH COMPENSATING FILTER (November 27, 1996)
  • K953246 — OCTOROLL (September 29, 1995)
  • K952871 — RIDGES PLUS (July 20, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K940306 — OCTOSTOP COMPENSATING FILTERS (September 6, 1994)
  • K935444 — OCTOSTOP(R) CHAIR (NEW MODEL (September 2, 1994)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K926069 — WRIST TRACTION (January 21, 1993)
  • K913659 — LITTLE PRISM (October 14, 1992)

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