MODIFIED STERILIZATION OF TUR APRONS— 510(k) K893634
Substantially EquivalentBrant-Wald Surgicals, Inc.
FDA 510(k) clearance K893634 for MODIFIED STERILIZATION OF TUR APRONS, Substantially Equivalent on 1989-06-23. Applicant: Brant-Wald Surgicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Brant-Wald Surgicals, Inc.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oak Ridge, TN, US
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More clearances from Brant-Wald Surgicals, Inc.
view allAdverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.