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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K002214
Device Name SINUSCOPE AND BACCESSORIES
Applicant
POLLUX ENDOSCOPY, INC.
2404 AIRPORT RD., SUITE 2
PLANT CITY,  FL  33567
Applicant Contact PRECIOUS J RESCH
Correspondent
POLLUX ENDOSCOPY, INC.
2404 AIRPORT RD., SUITE 2
PLANT CITY,  FL  33567
Correspondent Contact PRECIOUS J RESCH
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/24/2000
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
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