The following data is part of a premarket notification filed by Carl Zeiss Surgical Gmbh with the FDA for Intrabeam System.
| Device ID | K051055 |
| 510k Number | K051055 |
| Device Name: | INTRABEAM SYSTEM |
| Classification | System, Therapeutic, X-ray |
| Applicant | CARL ZEISS SURGICAL GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson CARL ZEISS SURGICAL GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539064028 | K051055 | 000 |