DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM

System, Therapeutic, X-ray

GULMAY MEDICAL LTD.

The following data is part of a premarket notification filed by Gulmay Medical Ltd. with the FDA for Darpac 2000 Superficial X-ray Therapy System.

Pre-market Notification Details

Device IDK962613
510k NumberK962613
Device Name:DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
ClassificationSystem, Therapeutic, X-ray
Applicant GULMAY MEDICAL LTD. UNIT 7, SHEPPERTON BUSINESS PARK, GOVETT AVENUE Shepperton, Middlesex,  GB Tw17 8ba
ContactG. Condliffe
CorrespondentG. Condliffe
GULMAY MEDICAL LTD. UNIT 7, SHEPPERTON BUSINESS PARK, GOVETT AVENUE Shepperton, Middlesex,  GB Tw17 8ba
Product CodeJAD  
CFR Regulation Number892.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-03
Decision Date1996-09-27

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