The following data is part of a premarket notification filed by Glenn Medical Systems, Inc. with the FDA for Fil 1520.
| Device ID | K101629 |
| 510k Number | K101629 |
| Device Name: | FIL 1520 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | GLENN MEDICAL SYSTEMS, INC. 511 12TH STREET, N.E. Ne Canton, OH 44704 |
| Contact | Gary Clevinger |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-10 |
| Decision Date | 2010-07-09 |