ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
FDA 510(k) clearance K980224 · decided 1998-04-02
Clearance details
- K-number
- K980224
- Device name
- ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
- Applicant
- Alexander Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-22
- Decision date
- 1998-04-02
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- MOQ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mason City, IA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VERTEBRAL ACCESS SYSTEM BY VIDACARE (K081713) | Vidacare Corporation | 2008-11-21 |
| NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 (K013133) | Nordix, Inc. | 2001-11-13 |
Recalls involving this device
No recalls on record reference this clearance.