Home / 510(k) Clearances / K802786

510(k) K802786

POROPLAST-EYE DRESSING by Secol Co. — Product Code HOY

K802786 is an FDA 510(k) premarket notification submitted by Secol Co. for the device "POROPLAST-EYE DRESSING". The FDA issued a decision of Substantially Equivalent on December 17, 1980. 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. Secol Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1980
Date Received
November 4, 1980
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 Secol Co.

  • K802790 — SOLVALINE (February 13, 1981)
  • K810111 — CELLONA PLASTER VARNISH (February 4, 1981)
  • K810110 — COBBLER'S CHIP SPLINTS (January 26, 1981)
  • K810109 — METAL SPLINTS (January 26, 1981)
  • K802794 — PRO-OPHTA STICKS (December 22, 1980)
  • K802793 — LOMATUELL OINTMENT DRESSING (December 18, 1980)
  • K802799 — EYE PADS (December 17, 1980)
  • K802791 — ZINC PASTE BANDAGE (December 17, 1980)
  • K802787 — METALLINE DRESSINGS (December 17, 1980)
  • K802797 — O.R. DRAPES (December 17, 1980)

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