The following data is part of a premarket notification filed by Pemaco, Inc. with the FDA for Pemaco Bite Wax Sheets.
| Device ID | K895563 |
| 510k Number | K895563 |
| Device Name: | PEMACO BITE WAX SHEETS |
| Classification | Wax, Dental, Intraoral |
| Applicant | PEMACO, INC. 1345 WEST LARK INDUSTRIAL PARK Fenton, MO 63026 |
| Contact | Richard Perkowski |
| Correspondent | Richard Perkowski PEMACO, INC. 1345 WEST LARK INDUSTRIAL PARK Fenton, MO 63026 |
| Product Code | EGD |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-11-06 |