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510(k) K850050

PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK by Professional Medical Services — Product Code HOZ

K850050 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK". The FDA issued a decision of Substantially Equivalent on April 23, 1985. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1985
Date Received
January 8, 1985
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 Professional Medical Services

  • K913094 — DISPOSABLE SLIDE VALVE MANIFOLD (January 27, 1992)
  • K910378 — PRESSURE MONITORING EXTENSION LINE (April 22, 1991)
  • K904508 — CONDOR ANALOG INFLATION SYRINGE (April 2, 1991)
  • K904954 — CONDOR DIGITAL INFLATION SYRINGE (January 16, 1991)
  • K902606 — RADIOPAQUE RULER (September 27, 1990)
  • K884577 — PROCEDURE READY TRAYS (August 1, 1989)
  • K890471 — PMS ANGIO DRAPE (February 27, 1989)
  • K884497 — CONTROL SYRINGE (December 12, 1988)
  • K872448 — BLOOD CONTAINMENT PACK (November 17, 1987)
  • K864555 — 3 RING ATTACHMENT (December 1, 1986)

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