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510(k) K061316

Device
MEDLINE SURGICAL SPONGE SCANNER
Applicant
MEDLINE INDUSTRIES, INC.
510(k) number
K061316
Product code
LWH  
Decision
Substantially Equivalent (SESE)
Decision date
2006-11-02
Date received
2006-05-11
Regulation
880.2740
Classification name
Counter, Sponge, Surgical
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LARA N SIMMONS
Address
One Medline Pl. Mundelein IL US 60060 60060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LWH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121274PIXEL APPGauss Surgical, Inc.,2012-06-27
K120473PIXEL APPGauss Surgical, Inc.,2012-04-09
K100551ORLOCATE SYSTEM MODEL ORL 100Haldor Advanced Technologies, Ltd.2010-08-12
K093557SMARTWAND-DTXClearcount Medical Solutions2009-12-18
K073180SMARTSPONGE PLUS SYSTEMClearcount Medical Solutions, Inc.2007-11-19
K071355SMARTSPONGE SYSTEMClearcount Medical Solutions, Inc.2007-05-24
K062642RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100ARf Surgical Systems, Inc.2006-11-02
K060076SURGICOUNT SAFETY-SPONGE SYSTEMSurgicount Medical2006-03-14
K982260MARKWELL GAUZE SPONGEMarkwell Intl., Inc.1998-08-12
K972302POCKET COUNT OR SAFETCOUNTSage Products, Inc.1997-07-25
K945144SPONGE COUNTMichael Fischer Assoc.1995-01-12
K912824DEVON SPONGE COUNTER BAGSDevon Industries, Inc.1991-08-26
K873555GORSK SPONGE CONTAINMENT SYSTEMGorsk, Inc.1987-10-23
K790538SPONGE COUNTERDevon Industries, Inc.1979-04-04

Legacy Summary#

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FDA Review#

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