The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Modification To Ventlab Hyperinflation Bag System.
| Device ID | K020281 |
| 510k Number | K020281 |
| Device Name: | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM |
| Classification | Resuscitator, Manual, Non Self-inflating |
| Applicant | VENTLAB CORP. 2934 HWY. 601 NORTH Mocksville, NC 27028 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker VENTLAB CORP. 2934 HWY. 601 NORTH Mocksville, NC 27028 |
| Product Code | NHK |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-02-11 |