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 |