The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Suh Vent Tube.
| Device ID | K910618 |
| 510k Number | K910618 |
| Device Name: | SUH VENT TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
| Contact | Stuart K Montgomery |
| Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 87 RUMFORD AVE. Waltham, MA 02154 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-06-28 |