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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 K915696
Device Name INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE
Applicant
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Applicant Contact ARTHUR SCHENCK
Correspondent
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Correspondent Contact ARTHUR SCHENCK
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/23/1991
Decision Date 11/24/1992
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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