CLEARVIEW ENDOSCOPE COVER


Device Classification Name

nasopharyngoscope (flexible or rigid)

510(k) Number K080740
Device Name CLEARVIEW ENDOSCOPE COVER
Applicant
INVOTEC INTERNATIONAL, INC.
6833 phillips industrial blvd.
jacksonville, 
FL 
32256 -3029

Applicant Contact jeffrey l aull
Correspondent
INVOTEC INTERNATIONAL, INC.
6833 phillips industrial blvd.
jacksonville, 
FL 
32256 -3029

Correspodent Contact jeffrey l aull
Regulation Number 874.4760
Classification Product Code
EOB  
Date Received 03/17/2008
Decision Date 12/31/2008
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