The following data is part of a premarket notification filed by Wieland Edelmetalle Gmbh & Co. with the FDA for Agc-gold Electrolyte For Agc-micro, Agc-gold Electrolyte For Agc-speed, Agc-goldbonder, Agc Glavanogold.
| Device ID | K001041 |
| 510k Number | K001041 |
| Device Name: | AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | WIELAND EDELMETALLE GMBH & CO. SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Contact | Gerhard Polzer |
| Correspondent | Gerhard Polzer WIELAND EDELMETALLE GMBH & CO. SCHWENNINGER STRABE 13 Pforzheim, DE D-75179 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-31 |
| Decision Date | 2000-05-23 |