The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Flo-guard Breathing Filter.
| Device ID | K121026 |
| 510k Number | K121026 |
| Device Name: | FLO-GUARD BREATHING FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Contact | Michael Zalewski |
| Correspondent | Michael Zalewski INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-04 |
| Decision Date | 2012-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267117895 | K121026 | 000 |