The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Noncon Robo Pachy F&a.
| Device ID | K062763 |
| 510k Number | K062763 |
| Device Name: | NONCON ROBO PACHY F&A |
| Classification | Microscope, Specular |
| Applicant | KONAN MEDICAL, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers KONAN MEDICAL, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Product Code | NQE |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2008-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582275250374 | K062763 | 000 |