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510(k) K896084

MICROSPEARS by Sparta Surgical Corp. — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1989
Date Received
October 19, 1989
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 Sparta Surgical Corp.

  • K965187 — SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD (August 1, 1997)
  • K945313 — SPARTA HYDROGEL WOUND DRESSING (January 12, 1995)
  • K922729 — SPARTA WET DRESSING, SODIUM CHLORIDE (November 23, 1992)
  • K905384 — DAVID SIMMONDS ANESTHESIA EXTENSION TUBES (March 22, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K896085 — SURGI-BRUSH (November 8, 1989)

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)