K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES


Device Classification Name

prosthesis, partial ossicular replacement

510(k) Number K080070
Device Name K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
Applicant
Grace Medical, Inc.
8500 wolf lake dr., ste. 110
memphis, 
TN 
38133

Applicant Contact jeff cobb
Correspondent
Grace Medical, Inc.
8500 wolf lake dr., ste. 110
memphis, 
TN 
38133

Correspodent Contact jeff cobb
Regulation Number 874.3450
Classification Product Code
ETB  
Date Received 01/10/2008
Decision Date 04/17/2008
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