PRIMADO SURGICAL DRILL


Device Classification Name

drill, surgical, ent (electric or pneumatic) including handpiece

510(k) Number K080722
Device Name PRIMADO SURGICAL DRILL
Applicant
NAKANISHI, INC.
1425 k street, n.w.
suite 1100
washington, 
DC 
20005

Applicant Contact keith a barritt
Correspondent
NAKANISHI, INC.
1425 k street, n.w.
suite 1100
washington, 
DC 
20005

Correspodent Contact keith a barritt
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 03/13/2008
Decision Date 09/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No