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510(k) K942513

SEIKO EYEGLASS FRAME by Seiko Optical Products of America, Inc. — Product Code HQZ

K942513 is an FDA 510(k) premarket notification submitted by Seiko Optical Products of America, Inc. for the device "SEIKO EYEGLASS FRAME". The FDA issued a decision of Substantially Equivalent on July 15, 1994. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842. Seiko Optical Products of America, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1994
Date Received
May 26, 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 Seiko Optical Products of America, Inc.

  • K900764 — SUNGLASS, NON-PRESCRIPTION (June 20, 1990)
  • K873245 — AR DIACOAT SINGLE VISION LENSES (October 5, 1987)
  • K861684 — SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) (June 9, 1986)

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)
  • K945450 — FRAME, SPECTACLE (November 22, 1994)

FDA data resources