510(k) K063202
K063202 is an FDA 510(k) premarket notification submitted by Procurement Technology Systems, LLC for the device "PRODERMA LIQUID BANDAGE". The FDA issued a decision of Substantially Equivalent on May 2, 2007. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2007
- Date Received
- October 20, 2006
- 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