The following data is part of a premarket notification filed by Carl Zeiss Surgical Gmbh with the FDA for Intrabeam Needle Applicator.
| Device ID | K110590 |
| 510k Number | K110590 |
| Device Name: | INTRABEAM NEEDLE APPLICATOR |
| Classification | System, Therapeutic, X-ray |
| Applicant | CARL ZEISS SURGICAL GMBH 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Judith A Brimacombe, Ma |
| Correspondent | Judith A Brimacombe, Ma CARL ZEISS SURGICAL GMBH 5160 HACIENDA DRIVE 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 | 2011-03-02 |
| Decision Date | 2012-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539101372 | K110590 | 000 |