ZILOS-TK
System, Assisted Reproduction Laser
HAMILTON THORNE BIOSCIENCES
The following data is part of a premarket notification filed by Hamilton Thorne Biosciences with the FDA for Zilos-tk.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858604006276 | K063636 | 000 |
Trademark Results [ZILOS-TK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZILOS-TK 78205724 2800416 Live/Registered |
HAMILTON THORNE, INC. 2003-01-22 |
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