The following data is part of a premarket notification filed by Mountain Medico, Inc. with the FDA for Pd Casta-h.
Device ID | K030632 |
510k Number | K030632 |
Device Name: | PD CASTA-H |
Classification | Alloy, Metal, Base |
Applicant | MOUNTAIN MEDICO, INC. 600 NORTH MOUNTAIN AVE., #D204 Upland, CA 91786 |
Contact | Ruth C Joline |
Correspondent | Ruth C Joline MOUNTAIN MEDICO, INC. 600 NORTH MOUNTAIN AVE., #D204 Upland, CA 91786 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-28 |
Decision Date | 2003-05-07 |