The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Manufacturing Co. Rechargeable Battery Part Number Gl825.
Device ID | K971234 |
510k Number | K971234 |
Device Name: | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 |
Classification | Accessories, Pump, Infusion |
Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Contact | Ken Heimendinger |
Correspondent | Ken Heimendinger ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
Product Code | MRZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-02 |
Decision Date | 1997-05-27 |