The following data is part of a premarket notification filed by Cry Iq Ab with the FDA for Cryoiq Derm, Cryoiq Pro, Cryoiq Equimed.
| Device ID | K172049 |
| 510k Number | K172049 |
| Device Name: | CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Cry IQ AB Apelrodsvagen 1 Onsala, SE 43932 |
| Contact | Stefan Skafte |
| Correspondent | Cherita James M Squared Associates, Inc 515 Eight Avenue, St 1212 New York, NY 10018 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-06 |
| Decision Date | 2017-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350006443619 | K172049 | 000 |
| 07350006443602 | K172049 | 000 |
| 07350006443596 | K172049 | 000 |
| 07350006443015 | K172049 | 000 |
| 07350006442100 | K172049 | 000 |
| 07350006441066 | K172049 | 000 |
| 07350006441011 | K172049 | 000 |