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510(k) K813156

ULTRA-WIDE SAFETY SPECTACLE FRAME by Zee Medical Products Co., Inc. — Product Code HQZ

K813156 is an FDA 510(k) premarket notification submitted by Zee Medical Products Co., Inc. for the device "ULTRA-WIDE SAFETY SPECTACLE FRAME". The FDA issued a decision of Substantially Equivalent on December 14, 1981. The device falls under product code HQZ (Frame, Spectacle), a Class I device regulated under 21 CFR 886.5842. Zee Medical Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1981
Date Received
November 6, 1981
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 Zee Medical Products Co., Inc.

  • K823501 — ZEE SPHYGMOMANOMETER (January 21, 1983)
  • K813016 — ZEE TRACTION SPLINT (November 24, 1981)
  • K812814 — ZEE SURGICAL INSTRUMENTS (November 6, 1981)
  • K812564 — ZEE LIFE SUPPORT AIR PANTS (October 23, 1981)
  • K812342 — ZEE EXTRICATION DEVICE (September 21, 1981)
  • K812284 — ZEE ELECTRODE-GEL (September 8, 1981)
  • K812022 — ZEE MANUAL RESUSCITATOR (July 31, 1981)

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)
  • K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES (December 15, 1994)
  • K945770 — OPTICAL FRAMES (December 15, 1994)
  • K945392 — SPECTACLE FRAME (December 15, 1994)
  • K945350 — FRAME, SPECTACLES (December 13, 1994)
  • K945342 — MAG-1 SPECTACLE FRAME (November 28, 1994)
  • K945340 — SPECTACLE FRAMES OR EYEGLASS FRAMES (November 22, 1994)
  • K945450 — FRAME, SPECTACLE (November 22, 1994)
  • K945123 — ARISTAR EYEWEAR, ESPRIT EYEWEAR (November 22, 1994)

FDA data resources