The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Child Size - Filter Flex (tm).
| Device ID | K893030 |
| 510k Number | K893030 |
| Device Name: | CHILD SIZE - FILTER FLEX (TM) |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1989-09-18 |