The following data is part of a premarket notification filed by Parkell with the FDA for Hema-primer.
| Device ID | K895750 |
| 510k Number | K895750 |
| Device Name: | HEMA-PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | J Gendusa |
| Correspondent | J Gendusa PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-12-21 |