The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Argeloy Partial (non-precious).
Device ID | K935829 |
510k Number | K935829 |
Device Name: | ARGELOY PARTIAL (NON-PRECIOUS) |
Classification | Alloy, Metal, Base |
Applicant | ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
Contact | Manohar L Malhotra |
Correspondent | Manohar L Malhotra ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-07 |
Decision Date | 1994-01-26 |