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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 K990213
Device Name HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
Applicant
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Applicant Contact JEFF COBB
Correspondent
GYRUS ENT L.L.C.
2925 APPLING RD.
BARTLETT,  TN  38133
Correspondent Contact JEFF COBB
Regulation Number874.4760
Classification Product Code
EOB  
Date Received01/22/1999
Decision Date 02/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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