The following data is part of a premarket notification filed by Talley Medical with the FDA for Tablegard Pressure Relieving Patient Warming Mattress, Model: Tg 700 Ht.
| Device ID | K080763 |
| 510k Number | K080763 |
| Device Name: | TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT |
| Classification | System, Thermal Regulating |
| Applicant | TALLEY MEDICAL 1070 E. WIELAND RD. Lansing, MI 48906 |
| Contact | Jack Van Dyke |
| Correspondent | Jack Van Dyke TALLEY MEDICAL 1070 E. WIELAND RD. Lansing, MI 48906 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-05-30 |
| Summary: | summary |