The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for H/s Catheter Set(61-3005, 61-3007, 61-3605, 61-3607).
| Device ID | K953034 |
| 510k Number | K953034 |
| Device Name: | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman, Ph.d. |
| Correspondent | Bernard Ackerman, Ph.d. ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1995-08-29 |