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 |