The following data is part of a premarket notification filed by Rms Div. with the FDA for Dw250 #91.
Device ID | K944557 |
510k Number | K944557 |
Device Name: | DW250 #91 |
Classification | Alloy, Gold-based Noble Metal |
Applicant | RMS DIV. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Lloyd V Ziemendorf |
Correspondent | Lloyd V Ziemendorf RMS DIV. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-16 |
Decision Date | 1994-11-03 |