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510(k) K942407

AMCON SLIP IN MYDRIATIC SUNGLASSES by Amcon Laboratories, Inc. — Product Code HOY

K942407 is an FDA 510(k) premarket notification submitted by Amcon Laboratories, Inc. for the device "AMCON SLIP IN MYDRIATIC SUNGLASSES". The FDA issued a decision of Substantially Equivalent on June 6, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1994
Date Received
May 20, 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 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)
  • K945351 — SHIELD, EYE, OPHTHALMIC (December 13, 1994)
  • K945346 — MAKROLON 2405 GOGGLES (LIGHT AND DARK) (November 22, 1994)
  • K941829 — SUN FILTERS/SHIELDS (May 17, 1994)
  • K930347 — SHAIDS PROTECTIVE GLASSES (April 29, 1994)
  • K940275 — UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD (March 24, 1994)

FDA data resources