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510(k) K934085

MODIFICATION OF SURGICAL EYESHIELD MASK by American Threshold Industries, Inc. — Product Code HOY

K934085 is an FDA 510(k) premarket notification submitted by American Threshold Industries, Inc. for the device "MODIFICATION OF SURGICAL EYESHIELD MASK". The FDA issued a decision of Substantially Equivalent on November 12, 1993. 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 Threshold Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1993
Date Received
August 20, 1993
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 Threshold Industries, Inc.

  • K971483 — SECURE-WRAP (TM) STERILIZATION WRAP (June 24, 1997)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN (September 25, 1995)
  • K952114 — KOOL GARD SINGLES GOWN (September 25, 1995)
  • K952116 — COVER GOWN (September 5, 1995)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K915740 — DISPOSABLE O.R. TOWEL, STERILE (June 22, 1992)
  • K912110 — DISPOSABLE O.R. TOWEL (July 25, 1991)
  • K894383 — DISPOSABLE SHOE COVER (September 12, 1989)

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