510(k) K914579
K914579 is an FDA 510(k) premarket notification submitted by Vitaphore Corp. for the device "SILVER FOAM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 21, 1992. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Vitaphore Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1992
- Date Received
- October 16, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type