MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS— 510(k) K901853
Substantially EquivalentJohnson & Johnson Medical, Inc.
FDA 510(k) clearance K901853 for MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS, Substantially Equivalent on 1991-01-28. Applicant: Johnson & Johnson Medical, Inc..
Clearance details
- Applicant
- Johnson & Johnson Medical, Inc.
- Product code
- Code NAD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, TX, US
Adverse events under product code NAD
product code NAD- Injury
- 431
- Malfunction
- 11,935
- Other
- 1
- Total
- 12,367
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.