The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Medi-therm Hyper/hypothermia System, Models Mta6900, Mta7900.
| Device ID | K100585 |
| 510k Number | K100585 |
| Device Name: | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 |
| Classification | System, Thermal Regulating |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Brian L Orwat |
| Correspondent | Brian L Orwat GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2011-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327348873 | K100585 | 000 |
| 07613327169331 | K100585 | 000 |
| 07613327169379 | K100585 | 000 |
| 57613327175054 | K100585 | 000 |
| 57613327175061 | K100585 | 000 |
| 57613327175078 | K100585 | 000 |
| 57613327175085 | K100585 | 000 |
| 07613327175097 | K100585 | 000 |
| 57613327175108 | K100585 | 000 |
| 07613327175110 | K100585 | 000 |
| 57613327175122 | K100585 | 000 |
| 57613327175139 | K100585 | 000 |
| 57613327175153 | K100585 | 000 |
| 57613327175351 | K100585 | 000 |
| 07613327277708 | K100585 | 000 |
| 07613327322576 | K100585 | 000 |
| 57613327169329 | K100585 | 000 |