The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Epic-flo.
| Device ID | K973976 |
| 510k Number | K973976 |
| Device Name: | EPIC-FLO |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | Nelson J Gendusa |
| Correspondent | Nelson J Gendusa PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-20 |
| Decision Date | 1997-12-04 |
| Summary: | summary |