The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Surgical Contra-angel Handpieces Types Ws-56e,ws-75e/km,ws-92 E/3,surgical Straight Handpieces Types, S-9, S-10, S-11.
| Device ID | K011061 |
| 510k Number | K011061 |
| Device Name: | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLAZER-STRASSE Buermoos, AT 5111 |
| Contact | Herbert Traschwandtner |
| Correspondent | Herbert Traschwandtner W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLAZER-STRASSE Buermoos, AT 5111 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-06 |
| Decision Date | 2001-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110023421 | K011061 | 000 |