The following data is part of a premarket notification filed by Lifeguard Medical Products, Inc. with the FDA for Lifeguard Bacterial And Viral Filter.
| Device ID | K880958 |
| 510k Number | K880958 |
| Device Name: | LIFEGUARD BACTERIAL AND VIRAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | LIFEGUARD MEDICAL PRODUCTS, INC. 7476 SHADELAND STATION WAY Indianapolis, IN 46256 |
| Contact | Craig Trimble |
| Correspondent | Craig Trimble LIFEGUARD MEDICAL PRODUCTS, INC. 7476 SHADELAND STATION WAY Indianapolis, IN 46256 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-04-27 |