The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Entended Line Accessories & Connectors.
| Device ID | K921512 |
| 510k Number | K921512 |
| Device Name: | ENTENDED LINE ACCESSORIES & CONNECTORS |
| 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 | 1992-03-24 |
| Decision Date | 1992-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267005017 | K921512 | 000 |
| 05030267005055 | K921512 | 000 |
| 05030267021819 | K921512 | 000 |
| 05030267005185 | K921512 | 000 |