VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER

System, Applicator, Radionuclide, Remote-controlled

VARIAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Varian Endometrial Applicator For Varisource Remote High Dose Rate Afterloader.

Pre-market Notification Details

Device IDK980576
510k NumberK980576
Device Name:VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant VARIAN MEDICAL SYSTEMS, INC. 3045 HANOVER ST. Palo Alto,  CA  94304 -1120
ContactLinda Nash
CorrespondentLinda Nash
VARIAN MEDICAL SYSTEMS, INC. 3045 HANOVER ST. Palo Alto,  CA  94304 -1120
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-17
Decision Date1998-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816389025134 K980576 000
00810563022193 K980576 000
00810563022186 K980576 000
00810563022179 K980576 000
00810563022162 K980576 000
00810563022155 K980576 000
00810563022148 K980576 000
00810563022131 K980576 000
00810563022124 K980576 000
00810563022117 K980576 000
00810563022094 K980576 000
00816389028357 K980576 000
00816389025035 K980576 000
00816389025127 K980576 000
00816389025110 K980576 000
00816389025103 K980576 000
00816389025097 K980576 000
00816389025080 K980576 000
00816389025073 K980576 000
00816389025066 K980576 000
00816389025059 K980576 000
00816389025042 K980576 000
00810563022100 K980576 000

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