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510(k) K844761

SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD by Medical Instrument Development Laboratories, Inc. — Product Code HOY

K844761 is an FDA 510(k) premarket notification submitted by Medical Instrument Development Laboratories, Inc. for the device "SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD". The FDA issued a decision of Substantially Equivalent on December 24, 1984. 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. Medical Instrument Development Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1984
Date Received
December 7, 1984
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 Medical Instrument Development Laboratories, Inc.

  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)
  • K992943 — VIT ENHANCER (December 10, 1999)
  • K971067 — DIGI-INJECTOR (September 19, 1997)
  • K950287 — UNIVIT PROBE (April 10, 1995)
  • K934600 — MICRODRIVE (July 27, 1994)
  • K932669 — SUPRA-VIT(TM) (June 3, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K924222 — MID LABS, INC. VIT MATE (January 27, 1993)

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)
  • K942407 — AMCON SLIP IN MYDRIATIC SUNGLASSES (June 6, 1994)
  • K941829 — SUN FILTERS/SHIELDS (May 17, 1994)
  • K930347 — SHAIDS PROTECTIVE GLASSES (April 29, 1994)

FDA data resources