510(k) K970170
K970170 is an FDA 510(k) premarket notification submitted by Richard G. Lindsay for the device "SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1997
- Date Received
- January 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractor, Vacuum, Fetal
- Device Class
- Class II
- Regulation Number
- 884.4340
- Review Panel
- OB
- Submission Type