T-GUARD— 510(k) K945537

Substantially Equivalent

Med ET AL Development

FDA 510(k) clearance K945537 for T-GUARD, Substantially Equivalent on 1995-03-23. Applicant: Med ET AL Development. Device class: 1.

Clearance details

Applicant
Med ET AL Development
Product code
Code LQX
Device class
Class 1
Regulation
21 CFR 890.3475
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Matthews, NC, US
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