The following data is part of a premarket notification filed by Phakos with the FDA for Frigitronics Adapter.
| Device ID | K180195 |
| 510k Number | K180195 |
| Device Name: | Frigitronics Adapter |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | Phakos 62 Rue Kléber Montreuil, FR 93100 |
| Contact | Olivier Aumaitre |
| Correspondent | J D Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HRN |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B564MVAD930 | K180195 | 000 |