The following data is part of a premarket notification filed by R2 Dermatology ,inc with the FDA for Dermal Cooling System.
| Device ID | K171398 |
| 510k Number | K171398 |
| Device Name: | Dermal Cooling System |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | R2 Dermatology ,Inc 2633 Camino Ramon, Suite 130 San Ramon, CA 94583 |
| Contact | Kristine Tatsutani |
| Correspondent | Bijesh Chandran R2 Dermatology ,Inc 2633 Camino Ramon, Suite 130 San Ramon, CA 94583 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-12 |
| Decision Date | 2017-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B563HP0030 | K171398 | 000 |
| B563HP0020 | K171398 | 000 |
| B563C20010 | K171398 | 000 |
| B563HP0050 | K171398 | 000 |
| B563HP0040 | K171398 | 000 |