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510(k) K945351

SHIELD, EYE, OPHTHALMIC by Taiwan Eva Industrial Co., Inc. — Product Code HOY

K945351 is an FDA 510(k) premarket notification submitted by Taiwan Eva Industrial Co., Inc. for the device "SHIELD, EYE, OPHTHALMIC". The FDA issued a decision of Substantially Equivalent on December 13, 1994. The device falls under product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)), a Class I device regulated under 21 CFR 886.4750. Taiwan Eva Industrial Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1994
Date Received
September 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device Class
Class I
Regulation Number
886.4750
Review Panel
OP
Submission Type

Other clearances by Taiwan Eva Industrial Co., Inc.

  • K952438 — SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) (September 12, 1995)
  • K945350 — FRAME, SPECTACLES (December 13, 1994)

Other clearances for product code HOY

  • K132042 — AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (April 28, 2014)
  • K050856 — LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (May 31, 2005)
  • K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (June 4, 1997)
  • K944700 — ARCTIC PREMIER SERIES (December 22, 1994)
  • K944857 — GOGGLE SAFEGUARD (December 15, 1994)
  • K945346 — MAKROLON 2405 GOGGLES (LIGHT AND DARK) (November 22, 1994)
  • K942407 — AMCON SLIP IN MYDRIATIC SUNGLASSES (June 6, 1994)
  • K941829 — SUN FILTERS/SHIELDS (May 17, 1994)
  • K930347 — SHAIDS PROTECTIVE GLASSES (April 29, 1994)
  • K940213 — UNIVERSAL CUSHIONED METAL EYE SHIELD (March 24, 1994)

FDA data resources