RESTLESS LEG DEVICE— 510(k) DEN110009

Name: FDA 510(k) clearance DEN110009
Creator: U.S. Food and Drug Administration
Published: 2013-12-18

Unknown

Mary M. Sorg (An Individual) Dba PJ Sleeper'S

FDA 510(k) clearance DEN110009 for RESTLESS LEG DEVICE, Unknown on 2013-12-18. Applicant: Mary M. Sorg (An Individual) Dba PJ Sleeper'S. Device class: 1.

Clearance details

Applicant: Mary M. Sorg (An Individual) Dba PJ Sleeper'S
Product code: Code OTX
Device class: Class 1
Regulation: 21 CFR 890.5760
Advisory panel: Physical Medicine
Date received: 2011-01-27
Decision date: 2013-12-18
Decision: Unknown
Clearance type: Post-NSE
Location: Waterford, PA, US

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