The following data is part of a premarket notification filed by Dallen Medical, Inc. with the FDA for Tensyn Band.
| Device ID | K131850 |
| 510k Number | K131850 |
| Device Name: | TENSYN BAND |
| Classification | Washer, Bolt Nut |
| Applicant | DALLEN MEDICAL, INC. 1046 Calle Recodo Ste G San Clemente, CA 92673 |
| Contact | Al Memmolo |
| Correspondent | Al Memmolo DALLEN MEDICAL, INC. 1046 Calle Recodo Ste G San Clemente, CA 92673 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-21 |
| Decision Date | 2013-11-15 |
| Summary: | summary |