The following data is part of a premarket notification filed by Haldor Advanced Technologies Ltd with the FDA for Orlocate System Model Orl 100.
| Device ID | K100551 |
| 510k Number | K100551 |
| Device Name: | ORLOCATE SYSTEM MODEL ORL 100 |
| Classification | Counter, Sponge, Surgical |
| Applicant | HALDOR ADVANCED TECHNOLOGIES LTD 107 SHAVEY TZION Pardes Hanna, IL 37052 |
| Contact | Sarit Gelbart Gal-rom |
| Correspondent | Sarit Gelbart Gal-rom HALDOR ADVANCED TECHNOLOGIES LTD 107 SHAVEY TZION Pardes Hanna, IL 37052 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-26 |
| Decision Date | 2010-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060356150229 | K100551 | 000 |
| 05060356150212 | K100551 | 000 |
| 05060356150205 | K100551 | 000 |
| 00724995220679 | K100551 | 000 |
| 00724995220624 | K100551 | 000 |
| 00724995220662 | K100551 | 000 |
| 00724995230050 | K100551 | 000 |