Home / 510(k) Clearances / K930435

510(k) K930435

SPECTACLE FRAMES by Venis DI A. Vendrame — Product Code HOI

K930435 is an FDA 510(k) premarket notification submitted by Venis DI A. Vendrame for the device "SPECTACLE FRAMES". The FDA issued a decision of Substantially Equivalent on September 20, 1993. The device falls under product code HOI (Spectacle, Magnifying), a Class I device regulated under 21 CFR 886.5840.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectacle, Magnifying
Device Class
Class I
Regulation Number
886.5840
Review Panel
OP
Submission Type

Other clearances for product code HOI

  • K943613 — NIL (September 21, 1994)
  • K931328 — PYRAMID SUNGLASSES/PYRAMID READING GLASSES (August 10, 1993)
  • K910329 — SUNGLASSES (March 12, 1991)
  • K854854 — SYSTEMS OF SIGHT LOW VISION EYEWARE (February 4, 1986)
  • K844716 — MAGNIFYING SPECTACLES W/PLASTIC LENSES (January 3, 1985)
  • K844038 — VISITEC MAGNIFYING SPECTACLES (November 29, 1984)
  • K842835 — BRILLETTE MODEL (November 21, 1984)
  • K820732 — LA VEL LATERAL VIEW EXTENSION LENS (May 3, 1982)
  • K813548 — UVEX MINI-SPECS (March 2, 1982)
  • K801733 — FENZL RETICLE (September 16, 1980)

FDA data resources