The following data is part of a premarket notification filed by Adn International Llc with the FDA for Strome-blitzer Cytology Balloon.
| Device ID | K182159 |
| 510k Number | K182159 |
| Device Name: | Strome-Blitzer Cytology Balloon |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | ADN International LLC 425 West 59th Street New York, NY 10019 |
| Contact | Marshall Strome |
| Correspondent | Eric Bannon AlvaMed Inc. 935 Great Plain Avenue, #166 Needham, MA 02492 |
| Product Code | EOX |
| Subsequent Product Code | BTR |
| Subsequent Product Code | FDX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-09 |
| Decision Date | 2019-06-13 |