The following data is part of a premarket notification filed by Atad Developments Ltd. with the FDA for Atad Ard Catheter.
| Device ID | K040625 |
| 510k Number | K040625 |
| Device Name: | ATAD ARD CATHETER |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | ATAD DEVELOPMENTS LTD. 70 YAKINTON ST. RAMAT ALMOGI Haifa, IL 34792 |
| Contact | Jack Atad |
| Correspondent | Jack Atad ATAD DEVELOPMENTS LTD. 70 YAKINTON ST. RAMAT ALMOGI Haifa, IL 34792 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-09 |
| Decision Date | 2005-01-18 |
| Summary: | summary |