The following data is part of a premarket notification filed by Orthocon, Llc with the FDA for Hemasorb Resorbable Hemostatic Bone Putty.
Device ID | K142339 |
510k Number | K142339 |
Device Name: | HEMASORB Resorbable Hemostatic Bone Putty |
Classification | Wax, Bone |
Applicant | ORTHOCON, LLC 1 Bridge Street -Suite 121 Irvington, NY 10533 |
Contact | Howard L Schrayer |
Correspondent | Howard L Schrayer ORTHOCON, LLC 1 Bridge Street -Suite 121 Irvington, NY 10533 |
Product Code | MTJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-21 |
Decision Date | 2014-09-26 |
Summary: | summary |