ENVOYCEM, MODEL 1640


Device Classification Name

cement, ear, nose and throat

510(k) Number K080032
Device Name ENVOYCEM, MODEL 1640
Applicant
ENVOY MEDICAL CORPORATION
5000 township parkway
saint paul, 
MN 
55110

Applicant Contact bernard (bud) horwath
Correspondent
ENVOY MEDICAL CORPORATION
5000 township parkway
saint paul, 
MN 
55110

Correspodent Contact bernard (bud) horwath
Regulation Number 872.3275
Classification Product Code
NEA  
Date Received 01/07/2008
Decision Date 02/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No