ALEXANDER BOX, BATTERY, RECHARGEABLE
FDA 510(k) clearance K963305 · decided 1997-04-17
Clearance details
- K-number
- K963305
- Device name
- ALEXANDER BOX, BATTERY, RECHARGEABLE
- Applicant
- Alexander Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-22
- Decision date
- 1997-04-17
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- BWA
- Device class
- 2
- Regulation number
- 878.4400
- 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 |
|---|---|---|
| E600B FOOTSWITCH (K874794) | Valleylab, Inc. | 1987-12-14 |
| EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 (K873809) | Zimmer Aspen Labs | 1987-11-20 |
Recalls involving this device
No recalls on record reference this clearance.