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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K915274
Device Name METAL HALIDE LIGHT SOURCE MODEL LM 250
Applicant
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact LORRAINE SCHWARTZ
Correspondent
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact LORRAINE SCHWARTZ
Regulation Number878.4580
Classification Product Code
FST  
Date Received11/25/1991
Decision Date 01/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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