FDA.report

510(k) K960312

Device
Rdi Cardiac Insulation Pad
Applicant
R D INTL.
510(k) number
K960312
Product code
DWP
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-19
Date received
1996-01-22
Regulation
870.4475
Classification name
Dilator, Vessel, Surgical
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
MIKE DAVIS
Address
304 Arborcrest Richardson TX US 75080 75080

FDA Registration Numbers

Source Documents

510(k) summary PDF

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