The following data is part of a premarket notification filed by Pmp Industries with the FDA for Hemo-de.
| Device ID | K822784 |
| 510k Number | K822784 |
| Device Name: | HEMO-DE |
| Classification | Agent, Clearing |
| Applicant | PMP INDUSTRIES CA |
| Product Code | KEM |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-14 |
| Decision Date | 1982-11-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEMO-DE 73380858 1256536 Dead/Cancelled |
Mitchell; Peter A. 1982-08-20 |