The following data is part of a premarket notification filed by Danninger Medical Technology, Inc. with the FDA for Ttu-100thermal Therapy Unit.
| Device ID | K913026 |
| 510k Number | K913026 |
| Device Name: | TTU-100THERMAL THERAPY UNIT |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Contact | David W.schlerf |
| Correspondent | David W.schlerf DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-12-13 |