510(k) K961124
K961124 is an FDA 510(k) premarket notification submitted by Rand Scientific Corp. for the device "THE NAUTILUS". The FDA issued a decision of Substantially Equivalent on April 19, 1996. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Rand Scientific Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1996
- Date Received
- March 21, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Nose, Internal
- Device Class
- Class II
- Regulation Number
- 878.3680
- Review Panel
- SU
- Submission Type