510(k) K013460
K013460 is an FDA 510(k) premarket notification submitted by Swift Delivery Products for the device "SWIFT LOW PROFILE CUP (PRO CUP)". The FDA issued a decision of Substantially Equivalent on January 17, 2002. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Swift Delivery Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2002
- Date Received
- October 18, 2001
- 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