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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K920746
Device Name VFC UNIT
Applicant
Tilane Corp.
1257 Florida Ave.
Rockledge,  FL  32955
Applicant Contact TIMOTHY LANE
Correspondent
Tilane Corp.
1257 Florida Ave.
Rockledge,  FL  32955
Correspondent Contact TIMOTHY LANE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received02/19/1992
Decision Date 06/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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