The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Hbp6 Settable, Resorbable Hemostatic Bone Paste.
| Device ID | K193052 |
| 510k Number | K193052 |
| Device Name: | HBP6 Settable, Resorbable Hemostatic Bone Paste |
| 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 | 2019-11-01 |
| Decision Date | 2020-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850391007221 | K193052 | 000 |
| 00850391007214 | K193052 | 000 |
| 00850391007207 | K193052 | 000 |
| 00850391007191 | K193052 | 000 |
| 00850391007368 | K193052 | 000 |
| 00850391007351 | K193052 | 000 |
| 00850391007344 | K193052 | 000 |
| 00850391007337 | K193052 | 000 |