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510(k) K945350

FRAME, SPECTACLES by Taiwan Eva Industrial Co., Inc. — Product Code HQZ

K945350 is an FDA 510(k) premarket notification submitted by Taiwan Eva Industrial Co., Inc. for the device "FRAME, SPECTACLES". The FDA issued a decision of Substantially Equivalent on December 13, 1994. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842. Taiwan Eva Industrial Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1994
Date Received
September 14, 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 Taiwan Eva Industrial Co., Inc.

  • K952438 — SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) (September 12, 1995)
  • K945351 — SHIELD, EYE, OPHTHALMIC (December 13, 1994)

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)
  • K945342 — MAG-1 SPECTACLE FRAME (November 28, 1994)
  • K945450 — FRAME, SPECTACLE (November 22, 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