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 |