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 IDK063636
510k NumberK063636
Device Name:ZILOS-TK
ClassificationSystem, Assisted Reproduction Laser
Applicant HAMILTON THORNE BIOSCIENCES 100 CUMMINGS CENTER, SUITE 465E Beverly,  MA  01915
ContactDouglas Hamilton
CorrespondentDouglas Hamilton
HAMILTON THORNE BIOSCIENCES 100 CUMMINGS CENTER, SUITE 465E Beverly,  MA  01915
Product CodeMRX  
CFR Regulation Number884.6200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-07
Decision Date2007-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858604006276 K063636 000

Trademark Results [ZILOS-TK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZILOS-TK
ZILOS-TK
78205724 2800416 Live/Registered
HAMILTON THORNE, INC.
2003-01-22

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