RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT


Device Classification Name

stimulator, nerve

510(k) Number K072736
Device Name RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
Applicant
RHYTHMLINK INTERNATIONAL, LLC
1256 first st. south extension
columbia, 
SC 
29209

Applicant Contact james mewborne
Correspondent
RHYTHMLINK INTERNATIONAL, LLC
1256 first st. south extension
columbia, 
SC 
29209

Correspodent Contact james mewborne
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 09/27/2007
Decision Date 01/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No