Caprolon
FDA 510(k) clearance K181320 · decided 2018-09-18
Clearance details
- K-number
- K181320
- Device name
- Caprolon
- Applicant
- Resorba Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2018-05-18
- Decision date
- 2018-09-18
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Nuremberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.