FDA.reportPublic FDA data

510(k) K003842

Device
PRESCOTT'S SURGICAL SPEAR
Applicant
Prescott'S, Inc.
510(k) number
K003842
Product code
HOZ
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-13
Date received
2000-12-12
Regulation
886.4790
Classification name
Sponge, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
PAUL REDNER
Address
P.O. Box 609 Monument CO US 80132 80132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.2013-10-30
K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.2013-10-29
K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.2009-10-23
K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.2008-12-15
K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.2001-08-24
K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, Inc.2001-06-26
K002279ML EYE SPEAR, MODEL ML 27 ESMed-Logics, Inc.2000-08-18
K993883M-PACT CORNEAL LIGHT SHIELDM-Pact Corp.1999-12-21
K990671DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPEHurricane Medical1999-05-10
K990749SOF-SUCTION FLUID EVACUATION SYSTEMX-Tech Medical, LLC1999-04-02
K982599THE FREMSTAD RINGOphthalmic Solutions, LLC1999-02-16
K974313HYDROFERA SURGICAL SPEARHydrofera, LLC1998-03-02
K972633ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.1997-12-17
K972693DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEARDeroyal Industries, Inc.1997-09-30
K971832IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICKM-Pact Worldwide Management Corp.1997-07-31