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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophagoscope (Flexible Or Rigid)
510(k) Number K182159
Device Name Strome-Blitzer Cytology Balloon
Applicant
Adn International, LLC
425 W. 59th St.
New York,  NY  10019
Applicant Contact Marshall Strome
Correspondent
AlvaMed, Inc.
935 Great Plain Ave.
#166
Needham,  MA  02492
Correspondent Contact Eric Bannon
Regulation Number874.4710
Classification Product Code
EOX  
Subsequent Product Codes
BTR   FDX  
Date Received08/09/2018
Decision Date 06/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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