The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Solder #206.
Device ID | K943271 |
510k Number | K943271 |
Device Name: | SOLDER #206 |
Classification | Alloy, Gold-based Noble Metal |
Applicant | ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
Contact | Manohar Lal Malhotra |
Correspondent | Manohar Lal Malhotra ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-07 |
Decision Date | 1994-08-01 |