The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Intrabeam Flat Applicator, Intrabeam Surface Applicator.
| Device ID | K130549 |
| 510k Number | K130549 |
| Device Name: | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR |
| Classification | System, Therapeutic, X-ray |
| Applicant | CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Contact | Sarah Harrington |
| Correspondent | Sarah Harrington CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-04 |
| Decision Date | 2013-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539101549 | K130549 | 000 |
| 04049539101457 | K130549 | 000 |
| 04049539101464 | K130549 | 000 |
| 04049539101471 | K130549 | 000 |
| 04049539101488 | K130549 | 000 |
| 04049539101501 | K130549 | 000 |
| 04049539101518 | K130549 | 000 |
| 04049539101525 | K130549 | 000 |
| 04049539101532 | K130549 | 000 |
| 04049539101440 | K130549 | 000 |