510(k) K832699
K832699 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "HYDRON WOUND DRESSING FAST SEAT KIT". The FDA issued a decision of Substantially Equivalent on April 27, 1984. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. National Patent Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 1984
- Date Received
- August 10, 1983
- 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