ADHESIVE WOUND COVER FILM— 510(k) K822080
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K822080 for ADHESIVE WOUND COVER FILM, Substantially Equivalent on 1982-10-15. Applicant: Hollister, Inc.. Device class: 1.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Code NAD
- Device class
- Class 1
- Regulation
- 21 CFR 878.4020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code NAD
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- K050483 — EVADRI BLADDER CONTROL SYSTEMS
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.