The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Alkaliner.
| Device ID | K873882 |
| 510k Number | K873882 |
| Device Name: | ALKALINER |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Contact | Harold A Opotow |
| Correspondent | Harold A Opotow ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-23 |
| Decision Date | 1988-02-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALKALINER 73753382 1567890 Dead/Expired |
ESPE FABRIK PHARMAZEUTISCHER PRAPARATE GMBH & CO. KG 1988-09-22 |