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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K951145
Device Name VMI 1000 SURGICAL PACEOMETER
Applicant
Vision Medical Instruments, Inc.
8147 Chagrin Mills Rd.
Chagrin Falls,  OH  44022
Applicant Contact KING G HEIPLE JR.
Correspondent
Vision Medical Instruments, Inc.
8147 Chagrin Mills Rd.
Chagrin Falls,  OH  44022
Correspondent Contact KING G HEIPLE JR.
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/13/1995
Decision Date 06/19/1995
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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