RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT


Device Classification Name

stimulator, nerve

510(k) Number K112435
Device Name RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
Applicant
RHYTHMLINK INTERNATIONAL, LLC
1140 first street south
columbia, 
SC 
29209

Applicant Contact james mewborne
Correspondent
RHYTHMLINK INTERNATIONAL, LLC
1140 first street south
columbia, 
SC 
29209

Correspodent Contact james mewborne
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 08/24/2011
Decision Date 09/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No