510(k) K935783
K935783 is an FDA 510(k) premarket notification submitted by Polymedica Industries, Inc. for the device "MITRAFLEX CAVITY WOUND DRESSING". The FDA issued a decision of SN on February 4, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Polymedica Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- February 4, 1994
- Date Received
- December 6, 1993
- 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