The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Manufacturing Rechargeable Battery (m1/t).
| Device ID | K970799 |
| 510k Number | K970799 |
| Device Name: | ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) |
| Classification | Dialyzer Reprocessing System |
| 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 | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-05-14 |