The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for H/s Catheter Set (5f), Model 61-5005; H/s Catheter Set (7f), Model 61-5007.
| Device ID | K020951 |
| 510k Number | K020951 |
| Device Name: | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Richard Hettenbach |
| Correspondent | Richard Hettenbach ACKRAD LABORATORIES 70 JACKSON DR. 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 | 2002-03-25 |
| Decision Date | 2002-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937016486 | K020951 | 000 |
| 20888937016479 | K020951 | 000 |