510(k) K012991
K012991 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "NEPTUNE WASTE MANAGEMENT STSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 2001. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Stryker Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2001
- Date Received
- September 6, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Exhaust, Surgical
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- HO
- Submission Type