The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Orthostat Bone Hemostat Matrix Applicator.
Device ID | K102762 |
510k Number | K102762 |
Device Name: | ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR |
Classification | Wax, Bone |
Applicant | ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington, NY 10533 |
Contact | Brian Kunst |
Correspondent | Brian Kunst 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 | 2010-09-24 |
Decision Date | 2011-02-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850391007054 | K102762 | 000 |