510(k) K090430
- Device
- BACKSTOP AND BACKSTOP INJECTOR
- Applicant
- PLUROMED, INC.
- 510(k) number
- K090430
- Product code
- ONJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-06-02
- Date received
- 2009-02-19
- Regulation
- 876.4680
- Classification name
- Dissolvable Gel For Preventing Ureteral Stone Migration
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES WILKIE
- Address
- 25-H Olympia Ave. Woburn MA US 01801 01801
FDA Registration Numbers#
- 3018179381
Source Documents#
Legacy Summary#
summary
FDA Review#
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