The following data is part of a premarket notification filed by Ackard Laboratories with the FDA for H/s Elliptosphere Catheter Set, Model 61-4005.
| Device ID | K013972 |
| 510k Number | K013972 |
| Device Name: | H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ACKARD LABORATORIES 70 JACKSON DR. P.O. BOX 1085 Cranford, NJ 07016 |
| Contact | Richard Hettenbach |
| Correspondent | Richard Hettenbach ACKARD LABORATORIES 70 JACKSON DR. P.O. BOX 1085 Cranford, NJ 07016 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2001-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937016455 | K013972 | 000 |
| 20888937016448 | K013972 | 000 |