PLANCET
FDA 510(k) clearance K113513 · decided 2012-07-13
Clearance details
- K-number
- K113513
- Device name
- PLANCET
- Applicant
- Micropoint Technologies Pte, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-28
- Decision date
- 2012-07-13
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- FMK
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Singapore, SG
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.