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510(k) K910329

SUNGLASSES by Cutler & Gross Sloan Optical , Ltd. — Product Code HOI

K910329 is an FDA 510(k) premarket notification submitted by Cutler & Gross Sloan Optical , Ltd. for the device "SUNGLASSES". The FDA issued a decision of Substantially Equivalent on March 12, 1991. 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
March 12, 1991
Date Received
January 25, 1991
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)
  • K930435 — SPECTACLE FRAMES (September 20, 1993)
  • K931328 — PYRAMID SUNGLASSES/PYRAMID READING GLASSES (August 10, 1993)
  • 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