O.B. APPLICATOR TAMPONS
FDA 510(k) clearance K953638 · decided 1995-10-20
Clearance details
- K-number
- K953638
- Device name
- O.B. APPLICATOR TAMPONS
- Applicant
- Personal Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-04
- Decision date
- 1995-10-20
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HIL
- Device class
- 2
- Regulation number
- 884.5460
- 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.