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510(k) K943423

SPECTACLE FRAMES by Galilee Optics — Product Code HQZ

K943423 is an FDA 510(k) premarket notification submitted by Galilee Optics for the device "SPECTACLE FRAMES". The FDA issued a decision of Substantially Equivalent on September 6, 1994. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842. Galilee Optics has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1994
Date Received
July 15, 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 by Galilee Optics

  • K960953 — SUNGLASSES (May 31, 1996)

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)
  • K945392 — SPECTACLE FRAME (December 15, 1994)
  • K945770 — OPTICAL FRAMES (December 15, 1994)
  • K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES (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)
  • K945450 — FRAME, SPECTACLE (November 22, 1994)

FDA data resources