The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Exhalation Valve.
| Device ID | K984481 |
| 510k Number | K984481 |
| Device Name: | EXHALATION VALVE |
| Classification | Valve, Non-rebreathing |
| Applicant | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Contact | Thomas R Gunerman |
| Correspondent | Thomas R Gunerman INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-16 |
| Decision Date | 1999-01-29 |