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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 K911073
Device Name PROBE REFILL KIT
Applicant
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Applicant Contact ARTHUR J SCHENCK
Correspondent
Interspec, Inc.
110 W. Butler Ave.
Ambler,  PA  19002
Correspondent Contact ARTHUR J SCHENCK
Regulation Number892.1570
Classification Product Code
ITX  
Date Received03/11/1991
Decision Date 06/06/1991
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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