510(k) K991920
K991920 is an FDA 510(k) premarket notification submitted by Dermaphylyx, Inc. for the device "DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on August 12, 1999. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Dermaphylyx, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1999
- Date Received
- June 7, 1999
- 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