K980224 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822. This device is classified as a Battery, Replacement, Rechargeable (Class I - General Controls, product code MOQ).
Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on April 2, 1998, 70 days after receiving the submission on January 22, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K980224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1998 |
| Decision Date | April 02, 1998 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MOQ — Battery, Replacement, Rechargeable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |