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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K921315
Device Name PENTAX XENON LIGHT SOURCE
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 Number876.1500
Classification Product Code
GCT  
Date Received03/18/1992
Decision Date 06/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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