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510(k) Premarket Notification

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Device Classification Name light, surgical, fiberoptic
510(k) NumberK915274
Device NameMETAL HALIDE LIGHT SOURCE MODEL LM 250
Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 ramland rd.
orangeburg,  NY  10962
Contactlorraine schwartz
Regulation Number878.4580
Classification Product Code
FST  
Date Received11/25/1991
Decision Date 01/23/1992
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Statement/purged 510(k)
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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