SOLSTICE XRAY RING MARKER PAD

System, X-ray, Film Marking, Radiographic

SOLSTICE CORP.

The following data is part of a premarket notification filed by Solstice Corp. with the FDA for Solstice Xray Ring Marker Pad.

Pre-market Notification Details

Device IDK925892
510k NumberK925892
Device Name:SOLSTICE XRAY RING MARKER PAD
ClassificationSystem, X-ray, Film Marking, Radiographic
Applicant SOLSTICE CORP. P.O. BOX 1177 Portland,  ME  04104
ContactDanforth Desena
CorrespondentDanforth Desena
SOLSTICE CORP. P.O. BOX 1177 Portland,  ME  04104
Product CodeJAC  
CFR Regulation Number892.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-17
Decision Date1993-05-18

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