FRASTEC CONFORMANT DRESSING, VARIOUS SIZES— 510(k) K885325
Substantially Equivalent for Some IndicationsFrastec Wound Care Products, Inc.
FDA 510(k) clearance K885325 for FRASTEC CONFORMANT DRESSING, VARIOUS SIZES, Substantially Equivalent for Some Indications on 1989-04-17. Applicant: Frastec Wound Care Products, Inc..
Clearance details
- Applicant
- Frastec Wound Care Products, Inc.
- Product code
- Code NAD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Bronx, NY, 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.