The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Chest Catheters/thoracic Catheters.
| Device ID | K851048 |
| 510k Number | K851048 |
| Device Name: | CHEST CATHETERS/THORACIC CATHETERS |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | MEDOVATIONS, INC. 11311 WEST LOCUST ST. Wauwatosa, WI 53222 |
| Contact | Sury R Shoney |
| Correspondent | Sury R Shoney MEDOVATIONS, INC. 11311 WEST LOCUST ST. Wauwatosa, WI 53222 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-14 |
| Decision Date | 1985-06-05 |