The following data is part of a premarket notification filed by Richard G. Lindsay with the FDA for Swift Delivery Product #002-vac Ex Cup W/vac Rel Valve.
| Device ID | K970170 |
| 510k Number | K970170 |
| Device Name: | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | RICHARD G. LINDSAY 6824 ELK CANYON RD. Oklahoma City, OK 73162 |
| Contact | Richard G Lindsay |
| Correspondent | Richard G Lindsay RICHARD G. LINDSAY 6824 ELK CANYON RD. Oklahoma City, OK 73162 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-09 |
| Decision Date | 1997-03-28 |
| Summary: | summary |