The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Permadyne Adhesive.
| Device ID | K875228 |
| 510k Number | K875228 |
| Device Name: | PERMADYNE ADHESIVE |
| Classification | Material, Impression Tray, Resin |
| Applicant | ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Contact | Harold Opotow |
| Correspondent | Harold Opotow ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-03-09 |