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510(k) K802794

PRO-OPHTA STICKS by Secol Co. — Product Code HOZ

K802794 is an FDA 510(k) premarket notification submitted by Secol Co. for the device "PRO-OPHTA STICKS". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Secol Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
November 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Secol Co.

  • K802790 — SOLVALINE (February 13, 1981)
  • K810111 — CELLONA PLASTER VARNISH (February 4, 1981)
  • K810109 — METAL SPLINTS (January 26, 1981)
  • K810110 — COBBLER'S CHIP SPLINTS (January 26, 1981)
  • K802793 — LOMATUELL OINTMENT DRESSING (December 18, 1980)
  • K802787 — METALLINE DRESSINGS (December 17, 1980)
  • K802799 — EYE PADS (December 17, 1980)
  • K802791 — ZINC PASTE BANDAGE (December 17, 1980)
  • K802786 — POROPLAST-EYE DRESSING (December 17, 1980)
  • K802797 — O.R. DRAPES (December 17, 1980)

Other clearances for product code HOZ

  • K132796 — SUNTOUCH EYE SPEAR (October 30, 2013)
  • K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (October 29, 2013)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K082460 — CENEFOM PVA SURGICAL SPEAR (December 15, 2008)
  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (June 26, 2001)
  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K993883 — M-PACT CORNEAL LIGHT SHIELD (December 21, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)

FDA data resources