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510(k) K052642

Device
SUTURING WASHER
Applicant
FIRST CALL, INC.
510(k) number
K052642
Product code
MAB  
Decision
Substantially Equivalent (SESE)
Decision date
2006-01-17
Date received
2005-09-26
Regulation
870.3450
Classification name
Marker, Cardiopulmonary Bypass (vein Marker)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DINA L WEISSMAN
Address
P.O. Box 205 Derby CT US 06418 06418

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001915GRAFT MARKER RINGT. Korossurgical Instruments Corp.2001-04-27
K894268C.A.B. RINGMedi-Sharp, Inc.1989-08-17

Legacy Summary#

summary

FDA Review#

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