The following data is part of a premarket notification filed by Hamilton Thorne Biosciences with the FDA for Zilos-tk.
Device ID | K063636 |
510k Number | K063636 |
Device Name: | ZILOS-TK |
Classification | System, Assisted Reproduction Laser |
Applicant | HAMILTON THORNE BIOSCIENCES 100 CUMMINGS CENTER, SUITE 465E Beverly, MA 01915 |
Contact | Douglas Hamilton |
Correspondent | Douglas Hamilton HAMILTON THORNE BIOSCIENCES 100 CUMMINGS CENTER, SUITE 465E Beverly, MA 01915 |
Product Code | MRX |
CFR Regulation Number | 884.6200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-07 |
Decision Date | 2007-04-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858604006276 | K063636 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZILOS-TK 78205724 2800416 Live/Registered |
HAMILTON THORNE, INC. 2003-01-22 |