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510(k) K894397

Device
WELCON LIGHT HANDLE
Applicant
WELCON, INC.
510(k) number
K894397
Product code
FTA  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-10
Date received
1989-07-20
Regulation
878.4580
Classification name
Light, Surgical, Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD P WELCH
Address
99 Hartford Ave. Providence RI US 02909 02909

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FTA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150532Universal Light Handle Cover, Light Handle CoverKey Surgical, Inc.2015-09-22
K142386Operating Room Light Handle AdapterLitex Manufacturing, Inc.2014-09-29
K133554SURGICAL LIGHT HANDLE COVERMicrotek Medical, Inc. an Ecolab Company2014-04-08
K133413IDSS SLCBlack Diamond Video2014-01-07
K112133OASYS SURGICAL LIGHT CONTROLLEROasys Healthcare2012-03-01
K102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.2010-11-23
K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.2008-07-30
K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.2006-01-19
K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.2005-08-11
K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, Inc.2003-01-30
K020640KSEA SCB MEDIA CONTROLKARL STORZ Endoscopy-America, Inc.2002-05-28
K020304DISPOSABLE LIGHT HANDLE AND ADAPTORAspen Surgical Products, Inc.2002-02-14
K993089DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTERDeroyal Cardiovascular, Inc.1999-10-14
K954940MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLEMdt Biologic Co.1996-01-17
K935102SATURN LIGHTBurton Medical Products Corp.1994-06-27

Legacy Summary#

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FDA Review#

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