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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Scanning, Nuclear
510(k) Number K920962
Device Name MULTIPLE ACCESSORY TO GAMMA CAMERAS
Applicant
Nu Age Products
2271-F Palmdale Blvd.,
Suite B-38
Palmdale,  CA  93550
Correspondent
Nu Age Products
2271-F Palmdale Blvd.,
Suite B-38
Palmdale,  CA  93550
Regulation Number892.1350
Classification Product Code
IYZ  
Date Received02/03/1992
Decision Date 04/17/1992
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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