The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Mfg. Rechargeable Battery (model M3/t).
Device ID | K970784 |
510k Number | K970784 |
Device Name: | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Contact | Stacey Hippen |
Correspondent | Stacey Hippen ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-04 |
Decision Date | 1997-05-14 |