510(k) K034029
- Device
- TI CLIP APPLIER
- Applicant
- GYRX, LLC
- 510(k) number
- K034029
- Product code
- NJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-05
- Date received
- 2003-12-29
- Regulation
- 878.4300
- Classification name
- Clip, Vas Deferens
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN S ZIMOVAN
- Address
- 11222 St. Johns Industrial Pkwy. N. Jacksonville FL US 32246 32246
Source Documents#
Other 510(k) Records For Product Code NJC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021745 | VASCLIP | Vmbc, LLC | 2002-08-20 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases