The following data is part of a premarket notification filed by Dallen Medical, Inc. with the FDA for Compressyn™ Staple.
| Device ID | K171473 |
| 510k Number | K171473 |
| Device Name: | Compressyn™ Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | Dallen Medical, Inc. 1046 Calle Recodo, Suite G San Clemente, CA 92673 |
| Contact | Al Memmolo |
| Correspondent | Al Memmolo Dallen Medical, Inc. 1046 Calle Recodo, Suite G San Clemente, CA 92673 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-19 |
| Decision Date | 2017-11-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COMPRESSYN 85922035 4893296 Live/Registered |
Dallen Medical, Inc. 2013-05-02 |
![]() COMPRESSYN 77648818 not registered Dead/Abandoned |
Dallen Medical, Inc. 2009-01-13 |