B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)

Arthroscope

DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for B-twin Bone Expander System (b-twin Be System).

Pre-market Notification Details

Device IDK032358
510k NumberK032358
Device Name:B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
ClassificationArthroscope
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington,  DC  20004
ContactJonanthan S Kahn
CorrespondentJonanthan S Kahn
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-30
Decision Date2003-12-17
Summary:summary

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