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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K000252
Device Name INSIGHT 4000 ENDOSCOPE
Applicant
INSIGHT INSTRUMENTS MFG., INC.
5400 SOUTH BRYANT AVE.
SANFORD,  FL  32773
Applicant Contact K. PETER LULOH
Correspondent
INSIGHT INSTRUMENTS MFG., INC.
5400 SOUTH BRYANT AVE.
SANFORD,  FL  32773
Correspondent Contact K. PETER LULOH
Regulation Number876.1500
Classification Product Code
MPA  
Date Received01/27/2000
Decision Date 10/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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