Nulife
FDA 510(k) clearance K210969 · decided 2021-11-03
Clearance details
- K-number
- K210969
- Device name
- Nulife
- Applicant
- Mrk Healthcare Pvt, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-03-31
- Decision date
- 2021-11-03
- Days to decision
- 217 days
- Clearance type
- Abbreviated
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Patan, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.