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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Film Marking, Radiographic
510(k) Number K925892
Device Name SOLSTICE XRAY RING MARKER PAD
Applicant
Solstice Corp.
P.O. Box 1177
Portland,  ME  04104
Applicant Contact DANFORTH DESENA
Correspondent
Solstice Corp.
P.O. Box 1177
Portland,  ME  04104
Correspondent Contact DANFORTH DESENA
Regulation Number892.1640
Classification Product Code
JAC  
Date Received11/17/1992
Decision Date 05/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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