The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Ino Therapeutics Inoblender, Model 10004.
| Device ID | K052663 |
| 510k Number | K052663 |
| Device Name: | INO THERAPEUTICS INOBLENDER, MODEL 10004 |
| Classification | Apparatus, Nitric Oxide, Backup Delivery |
| Applicant | INO THERAPEUTICS 7601-B MURPHY DRIVE Middleton, WI 53562 |
| Contact | Frederick Montgomery |
| Correspondent | Frederick Montgomery INO THERAPEUTICS 7601-B MURPHY DRIVE Middleton, WI 53562 |
| Product Code | MRO |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-27 |
| Decision Date | 2005-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867538000137 | K052663 | 000 |
| 00867538000120 | K052663 | 000 |