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510(k) K945450

FRAME, SPECTACLE by Kookje Apis Industrial Co. — Product Code HQZ

K945450 is an FDA 510(k) premarket notification submitted by Kookje Apis Industrial Co. for the device "FRAME, SPECTACLE". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
November 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Frame, Spectacle
Device Class
Class I
Regulation Number
886.5842
Review Panel
OP
Submission Type

Other clearances for product code HQZ

  • K952597 — VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN (September 12, 1995)
  • K944313 — SPECTACLE FRAME (March 28, 1995)
  • K945770 — OPTICAL FRAMES (December 15, 1994)
  • K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES (December 15, 1994)
  • K945392 — SPECTACLE FRAME (December 15, 1994)
  • K945350 — FRAME, SPECTACLES (December 13, 1994)
  • K945342 — MAG-1 SPECTACLE FRAME (November 28, 1994)
  • K945123 — ARISTAR EYEWEAR, ESPRIT EYEWEAR (November 22, 1994)
  • K945340 — SPECTACLE FRAMES OR EYEGLASS FRAMES (November 22, 1994)
  • K945323 — SPECTACLE FRAME (November 22, 1994)

FDA data resources