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510(k) K912443

Device
CANDELA INTRODUCER SHEATH SYSTEM
Applicant
CANDELA LASER CORP.
510(k) number
K912443
Product code
FDE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-16
Date received
1991-06-03
Regulation
876.1500
Classification name
Laparoscopy Kit
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GEORGE CHO
Address
530 Boston Post Rd. Wayland MA US 01778 01778

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FDE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955717ENDOSCOPE INTRODUCER KITMitsubishi Cable America, Inc.1996-04-18
K950924ASLAN KNOT PUSHERAslan Medical Technologies, Ltd.1995-03-14
K942677GEENEN/ZEBRA GUIDELINESBoston Scientific Corp1994-07-21

Legacy Summary#

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FDA Review#

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