The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for H/s Procedure Tray (5f), H/s Procedure Tray (7f), H/s Elliptosphere Procedure Tray & Multipurpose Procedure Tray.
| Device ID | K020954 |
| 510k Number | K020954 |
| Device Name: | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY |
| 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 | 2002-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937016576 | K020954 | 000 |
| 20888937016509 | K020954 | 000 |
| 20888937016493 | K020954 | 000 |
| 20888937016462 | K020954 | 000 |
| 20888937016431 | K020954 | 000 |
| 20888937016578 | K020954 | 000 |