O.B. SLENDER REGULAR TAMPON
FDA 510(k) clearance K870539 · decided 1987-03-18
Clearance details
- K-number
- K870539
- Device name
- O.B. SLENDER REGULAR TAMPON
- Applicant
- Personal Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-09
- Decision date
- 1987-03-18
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Milltown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.