The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Breathing Filters.
| Device ID | K911427 |
| 510k Number | K911427 |
| Device Name: | BREATHING FILTERS |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERSURGICAL, INC. P.O. BOX 642 CARRIAGE LANE PLACE Cazenovia, NY 13035 -0642 |
| Contact | Thomas R Guerman |
| Correspondent | Thomas R Guerman INTERSURGICAL, INC. P.O. BOX 642 CARRIAGE LANE PLACE Cazenovia, NY 13035 -0642 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267021727 | K911427 | 000 |
| 05030267021758 | K911427 | 000 |