510(k) K092829
K092829 is an FDA 510(k) premarket notification submitted by Christcot Medical Company for the device "INSERTEASE". The FDA issued a decision of Substantially Equivalent on December 2, 2009. The device falls under product code OOW (Applicator For Rectal Suppository), a Class I device regulated under 21 CFR 876.4730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2009
- Date Received
- September 15, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator For Rectal Suppository
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type
Intended for use in the insertion of suppositories into the rectum