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510(k) K810098

FOX EYE SHIELDS by American Hospital Supply Corp. — Product Code HOY

K810098 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "FOX EYE SHIELDS". The FDA issued a decision of Substantially Equivalent on February 27, 1981. 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. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1981
Date Received
January 19, 1981
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 American Hospital Supply Corp.

  • K854739 — AMERICAN STERILE SURGICAL ABSORBENT TOWEL (December 27, 1985)
  • K854759 — AMERICAN STERILE MAYO STAND TRAY (December 17, 1985)
  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K822990 — CONVERTORS PRIMARY WOUND DRESSING II (April 12, 1983)
  • K830343 — CONTAINER W/PRIMING SOLUTION (March 17, 1983)
  • K830301 — STRATUS FLUOROMETRIC ENZYME IMMUN0- (February 25, 1983)
  • K822755 — LATEX PENROSE TUBING (January 21, 1983)
  • K823418 — HEYER-SCHUTE UNIVERSAL URETERAL STENT (December 3, 1982)
  • K822966 — CONVERTORS DISPOSABLE DRESSING SPONGE (November 5, 1982)

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