The following data is part of a premarket notification filed by Merlyn Associates, Inc. with the FDA for Flexwarmer, Models Kz-1 And Kz-2.
| Device ID | K062644 |
| 510k Number | K062644 |
| Device Name: | FLEXWARMER, MODELS KZ-1 AND KZ-2 |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | MERLYN ASSOCIATES, INC. 1542 EDINGER AVE., SUITE A Tustin, CA 92780 |
| Contact | Karen Chen |
| Correspondent | Karen Chen MERLYN ASSOCIATES, INC. 1542 EDINGER AVE., SUITE A Tustin, CA 92780 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-06 |
| Decision Date | 2007-09-11 |