Home / 510(k) Clearances / K943641

510(k) K943641

SPECTACLE FRAME by Australian Optical Co., Inc. — Product Code HQZ

K943641 is an FDA 510(k) premarket notification submitted by Australian Optical Co., Inc. for the device "SPECTACLE FRAME". The FDA issued a decision of Substantially Equivalent on September 14, 1994. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842. Australian Optical Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
July 27, 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 Australian Optical Co., Inc.

  • K943562 — SUNGLASSES (September 14, 1994)
  • K943561 — SPECTACLE FRAME (September 14, 1994)
  • K943640 — SUNGLASS CLIP (September 14, 1994)
  • K935678 — SUNGLASS FRAME (February 16, 1994)
  • K930331 — SPECTACLE FRAME (December 8, 1993)
  • K911332 — SPECTACLE FRAME (May 6, 1991)
  • K910179 — OPTICAL FRAME (April 10, 1991)

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)
  • K945392 — SPECTACLE FRAME (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)
  • K945450 — FRAME, SPECTACLE (November 22, 1994)
  • K945340 — SPECTACLE FRAMES OR EYEGLASS FRAMES (November 22, 1994)
  • K945123 — ARISTAR EYEWEAR, ESPRIT EYEWEAR (November 22, 1994)

FDA data resources