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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name illuminator, fiberoptic, surgical field
510(k) Number K904681
Device Name VLS 5300 300W XENON LIGHT SOURCE
Applicant
VISTEK CORP.
70 SANTA FELICIA DR.
GOLETA,  CA  93117
Applicant Contact RICHARD MULLARKY
Correspondent
VISTEK CORP.
70 SANTA FELICIA DR.
GOLETA,  CA  93117
Correspondent Contact RICHARD MULLARKY
Regulation Number878.4580
Classification Product Code
HBI  
Date Received10/15/1990
Decision Date 12/18/1990
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
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