DEROYAL HYDROGEL DRESSING
FDA 510(k) clearance K915182 · decided 1992-04-21
Clearance details
- K-number
- K915182
- Device name
- DEROYAL HYDROGEL DRESSING
- Applicant
- Deroyal Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-15
- Decision date
- 1992-04-21
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- NAE
- Device class
- 1
- Regulation number
- 878.4022
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Powell, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.