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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K892934
Device Name 1 VIDEO TAPE RECORDER MODEL BK-224 H
Applicant
Perkins Mfg. Co.
1510 N.Washington Ave.
Dallas,  TX  75204
Applicant Contact DENNIS CARROLL
Correspondent
Perkins Mfg. Co.
1510 N.Washington Ave.
Dallas,  TX  75204
Correspondent Contact DENNIS CARROLL
Regulation Number892.1650
Classification Product Code
OXO  
Date Received04/21/1989
Decision Date 07/20/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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