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 |