The following data is part of a premarket notification filed by Asia Dynamics, Inc. with the FDA for Adi Catheter With Valve.
| Device ID | K952924 |
| 510k Number | K952924 |
| Device Name: | ADI CATHETER WITH VALVE |
| Classification | Catheter, Urethral |
| Applicant | ASIA DYNAMICS, INC. 5745 WEST HOWARD ST. Niles, IL 60714 |
| Contact | Christi Gerard |
| Correspondent | Christi Gerard ASIA DYNAMICS, INC. 5745 WEST HOWARD ST. Niles, IL 60714 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-26 |
| Decision Date | 1995-08-18 |