510(k) K032644
K032644 is an FDA 510(k) premarket notification submitted by Adamed , Ltd. for the device "KOLPEXIN SPHERE". The FDA issued a decision of Substantially Equivalent on May 28, 2004. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2004
- Date Received
- August 27, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pessary, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3575
- Review Panel
- OB
- Submission Type