510(k) K092829
- Device
- INSERTEASE
- Applicant
- CHRISTCOT MEDICAL COMPANY
- 510(k) number
- K092829
- Product code
- OOW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-02
- Date received
- 2009-09-15
- Regulation
- 876.4730
- Classification name
- Applicator For Rectal Suppository
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER D ENSIGN
- Address
- P.O. Box 104 Sudbury MA US 01776 01776
FDA Registration Numbers#
- 1417592
- 3004526603
- 3016159368
- 3008627398
- 3006542501
- 1422634
- 1928237
- 1423395
- 3005012805
- 3016965929
- 3005595283
Source Documents#
Legacy Summary#
summary
FDA Review#
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