510(k) K963287
K963287 is an FDA 510(k) premarket notification submitted by Swift Delivery Products for the device "VACUUM CUP (004SD)". The FDA issued a decision of Substantially Equivalent on October 28, 1996. 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
- October 28, 1996
- Date Received
- August 21, 1996
- 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