The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Condensate Collection Kit.
| Device ID | K954480 |
| 510k Number | K954480 |
| Device Name: | CONDENSATE COLLECTION KIT |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | NOVA-VENTRX 1974 RAYMOND DR. Northbrook, IL 60062 |
| Contact | Bernard R Paluch |
| Correspondent | Bernard R Paluch NOVA-VENTRX 1974 RAYMOND DR. Northbrook, IL 60062 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-26 |
| Decision Date | 1995-12-29 |