The following data is part of a premarket notification filed by Avacore Technologies, Inc. with the FDA for Rapid Thermal Exchange System.
| Device ID | K023934 |
| 510k Number | K023934 |
| Device Name: | RAPID THERMAL EXCHANGE SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | AVACORE TECHNOLOGIES, INC. 251 HIGH STREET, SUITE B Palo Alto, CA 94301 |
| Contact | Craig Coombs |
| Correspondent | Michael Kwan UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-11-26 |
| Decision Date | 2003-01-23 |
| Summary: | summary |