510(k) K920366
K920366 is an FDA 510(k) premarket notification submitted by Industrias Palex C/O Dma Med-Chem Corp. for the device "ULCUFLEX HYDROCOLOID POWDER". The FDA issued a decision of Substantially Equivalent on March 26, 1992. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Industrias Palex C/O Dma Med-Chem Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1992
- Date Received
- January 28, 1992
- 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