LUNAPADS
FDA 510(k) clearance K010986 · decided 2001-06-13
Clearance details
- K-number
- K010986
- Device name
- LUNAPADS
- Applicant
- Lunapads International Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-02
- Decision date
- 2001-06-13
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- NUQ
- Device class
- 1
- Regulation number
- 884.5435
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Vancouver Bc, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.