The following data is part of a premarket notification filed by Intra Special Catheters Gmbh with the FDA for Neo-pneumocath.
| Device ID | K955474 |
| 510k Number | K955474 |
| Device Name: | NEO-PNEUMOCATH |
| Classification | Catheter, Irrigation |
| Applicant | INTRA SPECIAL CATHETERS GMBH 1247 FLORIDA AVE. Palm Habor, FL 34683 |
| Contact | Pat Lamb |
| Correspondent | Pat Lamb INTRA SPECIAL CATHETERS GMBH 1247 FLORIDA AVE. Palm Habor, FL 34683 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-30 |
| Decision Date | 1996-02-13 |