The following data is part of a premarket notification filed by Galmaz Biotech S.l. with the FDA for Sirocco Thermal Regulating System.
| Device ID | K102856 |
| 510k Number | K102856 |
| Device Name: | SIROCCO THERMAL REGULATING SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | GALMAZ BIOTECH S.L. 1064 LABARGE Hudson, WI 54016 |
| Contact | Chris Zander |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-06-30 |
| Summary: | summary |