RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629

Electrosurgical, Cutting & Coagulation & Accessories

RUBICOR MEDICAL, INC.

The following data is part of a premarket notification filed by Rubicor Medical, Inc. with the FDA for Rubicor Encapsule Breast Biopsy Device, Model 30629.

Pre-market Notification Details

Device IDK032584
510k NumberK032584
Device Name:RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant RUBICOR MEDICAL, INC. 25 HARTFORD AVE. San Carlos,  CA  94070
ContactRobert J Chin
CorrespondentRobert J Chin
RUBICOR MEDICAL, INC. 25 HARTFORD AVE. San Carlos,  CA  94070
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-21
Decision Date2003-09-17
Summary:summary

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