EARPOPPER, MODEL EP-2000, EP-2100, EP-3000


Device Classification Name

device, inflation, middle ear

510(k) Number K073401
Device Name EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
Applicant
MICROMEDICS, INC.
1270 eagan industrial road
suite 120
eagan, 
MN 
55121

Applicant Contact tom lopac
Correspondent
MICROMEDICS, INC.
1270 eagan industrial road
suite 120
eagan, 
MN 
55121

Correspodent Contact tom lopac
Classification Product Code
MJV  
Date Received 12/04/2007
Decision Date 03/14/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No