The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Elcomed, Models Sa-200 C 230, Sa-200 230, Sa-200 C 115, Sa-200 115.
| Device ID | K014068 |
| 510k Number | K014068 |
| Device Name: | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLAZER-STRASSE Buermoos, AT 5111 |
| Contact | Ralf Benda |
| Correspondent | Ralf Benda W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLAZER-STRASSE Buermoos, AT 5111 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-05-03 |
| Summary: | summary |