The following data is part of a premarket notification filed by Plastiflex Group Nv with the FDA for Hybernite Rainout Control System.
| Device ID | K100104 |
| 510k Number | K100104 |
| Device Name: | HYBERNITE RAINOUT CONTROL SYSTEM |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | PLASTIFLEX GROUP NV 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William Greenrose |
| Correspondent | William Greenrose PLASTIFLEX GROUP NV 220 RIVER ROAD Claremont, NH 03743 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-04-14 |
| Summary: | summary |