OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305— 510(k) K903650
Substantially EquivalentMicro-Aire Surgical Instruments, Inc.
FDA 510(k) clearance K903650 for OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305, Substantially Equivalent on 1990-09-14. Applicant: Micro-Aire Surgical Instruments, Inc..
Clearance details
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Product code
- Code HWE
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
Adverse events under product code HWE
product code HWE- Death
- 4
- Injury
- 448
- Malfunction
- 19,856
- Other
- 2
- Total
- 20,310
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.