The following data is part of a premarket notification filed by Chesson Laboratory Associates, Inc. with the FDA for Chesson Labs Liquid Bandage.
Device ID | K083913 |
510k Number | K083913 |
Device Name: | CHESSON LABS LIQUID BANDAGE |
Classification | Bandage, Liquid |
Applicant | CHESSON LABORATORY ASSOCIATES, INC. 3100 TOWER BLVD., SUITE 117 Durham, NC 27707 |
Contact | Scott E Neuville |
Correspondent | Scott E Neuville CHESSON LABORATORY ASSOCIATES, INC. 3100 TOWER BLVD., SUITE 117 Durham, NC 27707 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-30 |
Decision Date | 2009-07-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00086634900040 | K083913 | 000 |
00866349000404 | K083913 | 000 |