510(k) K854344
K854344 is an FDA 510(k) premarket notification submitted by Advanced Ortho-Technology, Inc. for the device "AQUACEL SURGICAL PREP PADS". The FDA issued a decision of Substantially Equivalent on November 13, 1985. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Advanced Ortho-Technology, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1985
- Date Received
- October 29, 1985
- 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