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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Image Processing, Radiological
510(k) Number K002724
Device Name NUMALINK
Applicant
NUMA, INC.
10 NORTHERN BLVD., UNIT 12
AMHERST,  NH  03031
Applicant Contact LARRY SMITH
Correspondent
NUMA, INC.
10 NORTHERN BLVD., UNIT 12
AMHERST,  NH  03031
Correspondent Contact LARRY SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/31/2000
Decision Date 11/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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