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510(k) K894268

Device
C.A.B. RING
Applicant
MEDI-SHARP, INC.
510(k) number
K894268
Product code
MAB  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-17
Date received
1989-06-22
Regulation
870.3450
Classification name
Marker, Cardiopulmonary Bypass (vein Marker)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
A.L MARTIN
Address
P.O. Box 1864 Stafford TX US 77497 77497

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052642SUTURING WASHERFirst Call, Inc.2006-01-17
K001915GRAFT MARKER RINGT. Korossurgical Instruments Corp.2001-04-27

Legacy Summary#

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FDA Review#

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