510(k) K013289
K013289 is an FDA 510(k) premarket notification submitted by Bioteque America, Inc. for the device "BIOTEQUE VAGINAL PESSARIES". The FDA issued a decision of Substantially Equivalent on December 27, 2001. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Bioteque America, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2001
- Date Received
- October 2, 2001
- 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