The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Meron Application Capsules.
| Device ID | K130421 |
| 510k Number | K130421 |
| Device Name: | MERON APPLICATION CAPSULES |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | T. Gerkensmeier |
| Correspondent | T. Gerkensmeier VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-20 |
| Decision Date | 2013-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620711106260 | K130421 | 000 |