Interlude 100% Cotton Tampon
FDA 510(k) clearance K181911 · decided 2018-11-02
Clearance details
- K-number
- K181911
- Device name
- Interlude 100% Cotton Tampon
- Applicant
- Albaad Fem
- Decision
- Substantially Equivalent
- Date received
- 2018-07-17
- Decision date
- 2018-11-02
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Caesarea Ind. Park, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.