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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 K030857
Device Name MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
Applicant
MAHE INTL., INC.
490 CRAIGHEAD
NASHVILLE,  TN  37204
Applicant Contact PAUL CART
Correspondent
MAHE INTL., INC.
490 CRAIGHEAD
NASHVILLE,  TN  37204
Correspondent Contact PAUL CART
Regulation Number874.4760
Classification Product Code
EOB  
Date Received03/18/2003
Decision Date 10/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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