The following data is part of a premarket notification filed by Medical Repackers Co. with the FDA for Accutherm Pts-200.
| Device ID | K890575 |
| 510k Number | K890575 |
| Device Name: | ACCUTHERM PTS-200 |
| Classification | System, Thermal Regulating |
| Applicant | MEDICAL REPACKERS CO. P.O. BOX 1500 Fort Payne, AL 35967 |
| Contact | Billy A Hodges |
| Correspondent | Billy A Hodges MEDICAL REPACKERS CO. P.O. BOX 1500 Fort Payne, AL 35967 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-05-05 |