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510(k) K943613

NIL by Sing Wah International Enterprises , Ltd. — Product Code HOI

K943613 is an FDA 510(k) premarket notification submitted by Sing Wah International Enterprises , Ltd. for the device "NIL". The FDA issued a decision of Substantially Equivalent on September 21, 1994. The device falls under product code HOI (Spectacle, Magnifying), a Class I device regulated under 21 CFR 886.5840. Sing Wah International Enterprises , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1994
Date Received
July 27, 1994
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 Sing Wah International Enterprises , Ltd.

  • K943263 — NIL (August 15, 1994)

Other clearances for product code HOI

  • K930435 — SPECTACLE FRAMES (September 20, 1993)
  • 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