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 |