The following data is part of a premarket notification filed by Carl Zeiss Surgical Gmbh with the FDA for Intrabeam System With Balloon Applicator And Cbg Sets.
| Device ID | K090584 |
| 510k Number | K090584 |
| Device Name: | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS |
| Classification | System, Therapeutic, X-ray |
| Applicant | CARL ZEISS SURGICAL GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mark W Sheehan |
| Correspondent | Mark W Sheehan CARL ZEISS SURGICAL GMBH 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-11-24 |
| Summary: | summary |