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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name goniometer, ac-powered
510(k) Number K893903
Device Name KRONAMAX KUBE
Applicant
PHYSICIANS DIGITAL CO.
12600 SAN PABLO AVE.
SUITE A
RICHMOND,  CA  94805
Applicant Contact DAVID R SCHULTZ
Correspondent
PHYSICIANS DIGITAL CO.
12600 SAN PABLO AVE.
SUITE A
RICHMOND,  CA  94805
Correspondent Contact DAVID R SCHULTZ
Regulation Number888.1500
Classification Product Code
KQX  
Date Received05/30/1989
Decision Date 11/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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