The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Prostatic Urethro. Balloon Dilatation Catheter.
| Device ID | K873295 |
| 510k Number | K873295 |
| Device Name: | PROSTATIC URETHRO. BALLOON DILATATION CATHETER |
| Classification | Dilator, Urethral |
| Applicant | MEDI-TECH, INC. 480 PLESANT ST. P.O. BOX 7407 Watertown, MA 02272 |
| Contact | Albert P Seprinski |
| Correspondent | Albert P Seprinski MEDI-TECH, INC. 480 PLESANT ST. P.O. BOX 7407 Watertown, MA 02272 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-17 |
| Decision Date | 1989-07-31 |