The following data is part of a premarket notification filed by Romidan Ltd with the FDA for Romiapex Model A-15.
| Device ID | K101054 |
| 510k Number | K101054 |
| Device Name: | ROMIAPEX MODEL A-15 |
| Classification | Locator, Root Apex |
| Applicant | ROMIDAN LTD 5 SIMCHA HOLZBERG ST. Kiryat-ono, IL 55022 |
| Contact | Eitan Margalit |
| Correspondent | Eitan Margalit ROMIDAN LTD 5 SIMCHA HOLZBERG ST. Kiryat-ono, IL 55022 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-15 |
| Decision Date | 2010-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290114359009 | K101054 | 000 |
| 07290114353007 | K101054 | 000 |