The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Breathing Filters 1942t/1941t/2014t.
| Device ID | K925462 |
| 510k Number | K925462 |
| Device Name: | BREATHING FILTERS 1942T/1941T/2014T |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERSURGICAL, INC. P.O. BOX 642 CARRIAGE LANE PLACE Cazenovia, NY 13035 -0642 |
| Contact | Alan I Becker |
| Correspondent | Alan I Becker 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 | 1992-10-29 |
| Decision Date | 1993-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267021703 | K925462 | 000 |
| 05030267021574 | K925462 | 000 |