510(k) K083087
K083087 is an FDA 510(k) premarket notification submitted by Polichem S.A for the device "ECOCEL". The FDA issued a decision of Substantially Equivalent on August 7, 2009. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Polichem S.A has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2009
- Date Received
- October 16, 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