The following data is part of a premarket notification filed by Swift Delivery Products with the FDA for Swift Low Profile Cup (pro Cup).
| Device ID | K013460 |
| 510k Number | K013460 |
| Device Name: | SWIFT LOW PROFILE CUP (PRO CUP) |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | SWIFT DELIVERY PRODUCTS 6824 ELK CANYON RD. Oklahoma City, OK 73162 |
| Contact | Richard G Lindsay |
| Correspondent | Richard G Lindsay SWIFT DELIVERY PRODUCTS 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 | 2001-10-18 |
| Decision Date | 2002-01-17 |