INSERTEASE
Applicator For Rectal Suppository
CHRISTCOT MEDICAL COMPANY
The following data is part of a premarket notification filed by Christcot Medical Company with the FDA for Insertease.
Pre-market Notification Details
| Device ID | K092829 |
| 510k Number | K092829 |
| Device Name: | INSERTEASE |
| Classification | Applicator For Rectal Suppository |
| Applicant | CHRISTCOT MEDICAL COMPANY PO BOX 104 Sudbury, MA 01776 |
| Contact | Jennifer D Ensign |
| Correspondent | Jennifer D Ensign CHRISTCOT MEDICAL COMPANY PO BOX 104 Sudbury, MA 01776 |
| Product Code | OOW |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-15 |
| Decision Date | 2009-12-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868648000000 | K092829 | 000 |
| 00868648000017 | K092829 | 000 |
Trademark Results [INSERTEASE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSERTEASE 85103568 3965075 Dead/Cancelled |
Christcot Medical Company 2010-08-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.