GLOBUS PREMIUM MUSCLE STIMULATOR— 510(k) K061632

Substantially Equivalent

Domino S.R.L.

FDA 510(k) clearance K061632 for GLOBUS PREMIUM MUSCLE STIMULATOR, Substantially Equivalent on 2007-04-30. Applicant: Domino S.R.L.. Device class: 2.

Clearance details

Applicant
Domino S.R.L.
Product code
Code NGX
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Hartford, CT, US
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