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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Manual, Radiographic
510(k) Number K974240
Device Name LIGHTLINE-M
Applicant
Wuestec Medical, Inc.
421 Holcolmbe Ave.
Mobile,  AL  36606
Applicant Contact KRISTI WHITE
Correspondent
Wuestec Medical, Inc.
421 Holcolmbe Ave.
Mobile,  AL  36606
Correspondent Contact KRISTI WHITE
Regulation Number892.1610
Classification Product Code
IZX  
Date Received11/12/1997
Decision Date 12/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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