510(k) K102445
K102445 is an FDA 510(k) premarket notification submitted by Rostam , Ltd. for the device "ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS". The FDA issued a decision of Substantially Equivalent on Nov 10, 2010. The device falls under product code HEB (Tampon, Menstrual, Unscented), a Class II device regulated under 21 CFR 884.5470. Rostam , Ltd. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 10, 2010
- Date Received
- Aug 26, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tampon, Menstrual, Unscented
- Device Class
- Class II
- Regulation Number
- 884.5470
- Review Panel
- OB
- Submission Type
- 510(k)
An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.