The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Accessories & Connectors, 22mm-15mm-8.5mm.
| Device ID | K911425 |
| 510k Number | K911425 |
| Device Name: | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM |
| Classification | Connector, Airway (extension) |
| Applicant | INTERSURGICAL, INC. P.O. BOX 642 CARRIAGE LANE PLACE Cazenovia, NY 13035 -0642 |
| Contact | Thomas R Gunerman |
| Correspondent | Thomas R Gunerman INTERSURGICAL, INC. P.O. BOX 642 CARRIAGE LANE PLACE Cazenovia, NY 13035 -0642 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267090020 | K911425 | 000 |
| 00816472022675 | K911425 | 000 |