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 Gl625.
| Device ID | K972780 | 
| 510k Number | K972780 | 
| Device Name: | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 | 
| 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 | 1997-07-25 | 
| Decision Date | 1997-10-20 |