The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Bacterial Filter, Model Bf100.
| Device ID | K030271 |
| 510k Number | K030271 |
| Device Name: | VENTLAB BACTERIAL FILTER, MODEL BF100 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | VENTLAB CORP. 2934 HWY. 601 NORTH Mocksville, NC 27028 |
| Contact | Robert M Kelly |
| Correspondent | Robert M Kelly VENTLAB CORP. 2934 HWY. 601 NORTH Mocksville, NC 27028 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-27 |
| Decision Date | 2003-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391517936339 | K030271 | 000 |
| 05391517936322 | K030271 | 000 |
| 05391517936315 | K030271 | 000 |
| 05391517936308 | K030271 | 000 |
| 20193489025016 | K030271 | 000 |
| 20193489085607 | K030271 | 000 |