The following data is part of a premarket notification filed by Konan, Inc. with the FDA for Konan Noncon Robo Pachy Specular Microscope And Opticl Pachymeter.
| Device ID | K980357 |
| 510k Number | K980357 |
| Device Name: | KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KONAN, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Contact | George H Myers |
| Correspondent | George H Myers KONAN, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-29 |
| Decision Date | 1998-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582275250107 | K980357 | 000 |