510(k) K083913
K083913 is an FDA 510(k) premarket notification submitted by Chesson Laboratory Associates, Inc. for the device "CHESSON LABS LIQUID BANDAGE". The FDA issued a decision of Substantially Equivalent on July 31, 2009. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Chesson Laboratory Associates, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2009
- Date Received
- December 30, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type