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510(k) K931328

PYRAMID SUNGLASSES/PYRAMID READING GLASSES by Pyramid — Product Code HOI

K931328 is an FDA 510(k) premarket notification submitted by Pyramid for the device "PYRAMID SUNGLASSES/PYRAMID READING GLASSES". The FDA issued a decision of Substantially Equivalent on August 10, 1993. The device falls under product code HOI (Spectacle, Magnifying), a Class I device regulated under 21 CFR 886.5840. Pyramid has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1993
Date Received
March 16, 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 by Pyramid

  • K914425 — PYRAMID SUNGLASSES/READING GLASSES (December 31, 1991)

Other clearances for product code HOI

  • K943613 — NIL (September 21, 1994)
  • K930435 — SPECTACLE FRAMES (September 20, 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