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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K990238
Device Name LONGPORT MODEL LDS -1
Applicant
Longport, Inc.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Applicant Contact MICHAEL G FARROW
Correspondent
Longport, Inc.
1625 K St. NW
Suite 1000
Washington,  DC  20006
Correspondent Contact MICHAEL G FARROW
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/25/1999
Decision Date 06/23/1999
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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