The following data is part of a premarket notification filed by Southwest Technologies, Inc. with the FDA for Stimulen Collagen.
| Device ID | K030774 |
| 510k Number | K030774 |
| Device Name: | STIMULEN COLLAGEN |
| Classification | Dressing, Wound, Collagen |
| Applicant | SOUTHWEST TECHNOLOGIES, INC. 1746 LEVEE RD. Kansas City, MO 64116 |
| Contact | Edward I Stout |
| Correspondent | Edward I Stout SOUTHWEST TECHNOLOGIES, INC. 1746 LEVEE RD. Kansas City, MO 64116 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2004-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00745713095157 | K030774 | 000 |
| 00745713995013 | K030774 | 000 |
| 00745713086025 | K030774 | 000 |
| 00745713086018 | K030774 | 000 |