The following data is part of a premarket notification filed by Life Shield Healthcare Products, Inc. with the FDA for Life Shield Healthcare Products Breathing Filter.
| Device ID | K925388 |
| 510k Number | K925388 |
| Device Name: | LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville, IN 46060 |
| Contact | Timothy D Struthers |
| Correspondent | Timothy D Struthers LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville, IN 46060 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-26 |
| Decision Date | 1993-05-11 |