NORSEN DEBRIDER
FDA 510(k) clearance K821801 · decided 1982-07-28
Clearance details
- K-number
- K821801
- Device name
- NORSEN DEBRIDER
- Applicant
- Bel-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-15
- Decision date
- 1982-07-28
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GED
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROTET SOAP & WASH MITT (K830259) | Ritmed, Inc. | 1983-05-09 |
Recalls involving this device
No recalls on record reference this clearance.