The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty.
Device ID | K123243 |
510k Number | K123243 |
Device Name: | HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY |
Classification | Wax, Bone |
Applicant | ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington, NY 10533 |
Contact | Howard Schrayer |
Correspondent | Howard Schrayer ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington, NY 10533 |
Product Code | MTJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-17 |
Decision Date | 2013-04-05 |
Summary: | summary |