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510(k) K933268

Device
CANDELA GUIDEWIRE
Applicant
CANDELA LASER CORP.
510(k) number
K933268
Product code
NWU  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-10
Date received
1993-07-06
Regulation
876.1500
Classification name
Endoscope Introducer Kit
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS R VARRICCHIONE
Address
530 Boston Post Rd. Wayland MA US 01778 01778

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NWU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERAmerican Pharmaseal Div. Ahsc1987-12-03
K813332BRISTOL BALLON INTRODUCER, MANDRIL SETInmed Corp.1981-12-14

Legacy Summary#

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FDA Review#

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