SINUSCOPE AND BACCESSORIES

information about

Device Classification Name

nasopharyngoscope (flexible or rigid)

510(k) Number K002214
Device Name SINUSCOPE AND BACCESSORIES
Original Applicant
POLLUX ENDOSCOPY, INC.
2404 airport rd., suite 2
plant city, 
FL 
33567

Original Contact precious j resch
Regulation Number 874.4760
Classification Product Code
EOB  
Date Received 07/24/2000
Decision Date 11/21/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No