The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Surgical Handpieces, Mikro Saw Handpieces.
| Device ID | K080939 |
| 510k Number | K080939 |
| Device Name: | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES |
| Classification | Handpiece, Rotary Bone Cutting |
| Applicant | W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE Buermoos, AT 5111 |
| Contact | Gabriele Wienbeck |
| Correspondent | Gabriele Wienbeck W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE Buermoos, AT 5111 |
| Product Code | KMW |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-07-29 |
| Summary: | summary |