The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Hemasorb Apply.
Device ID | K121953 |
510k Number | K121953 |
Device Name: | HEMASORB APPLY |
Classification | Wax, Bone |
Applicant | ORTHOCON, INC. 1 Bridge St Ste 121 Irvington, NY 10533 |
Contact | Richard Kronenthal, Phd |
Correspondent | Richard Kronenthal, Phd ORTHOCON, INC. 1 Bridge St Ste 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 | 2012-07-03 |
Decision Date | 2012-11-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEMASORB APPLY 85234050 4180264 Live/Registered |
ABYRX, INC. 2011-02-04 |
HEMASORB APPLY 85226822 4183991 Live/Registered |
ABYRX, INC. 2011-01-26 |