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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K850020
Device Name PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
Applicant
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact MARCIA C STARK
Correspondent
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact MARCIA C STARK
Regulation Number876.1500
Classification Product Code
FDS  
Date Received01/04/1985
Decision Date 07/09/1985
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
Recalls CDRH Recalls
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