The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Hard Reliner.
Device ID | K011277 |
510k Number | K011277 |
Device Name: | HARD RELINER |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
Contact | Jurgen Engelbrecht |
Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-26 |
Decision Date | 2001-06-26 |