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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transilluminator, ac-powered
510(k) Number K945877
Device Name WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT
Applicant
WELLS JOHNSON CO.
8075 E RESEARCH CT., STE. 101
P.O. BOX 18230
TUCSON,  AZ  85731 -8230
Applicant Contact BRENDA HUNT
Correspondent
WELLS JOHNSON CO.
8075 E RESEARCH CT., STE. 101
P.O. BOX 18230
TUCSON,  AZ  85731 -8230
Correspondent Contact BRENDA HUNT
Regulation Number886.1945
Classification Product Code
HJM  
Date Received12/01/1994
Decision Date 03/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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