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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K902977
Device Name K3 COMPUTER SYSTEMS
Applicant
Donald L. King M.D.
19 Searles Rd.
Darien,  CT  06820
Applicant Contact KING, M.D.
Correspondent
Donald L. King M.D.
19 Searles Rd.
Darien,  CT  06820
Correspondent Contact KING, M.D.
Regulation Number870.2120
Classification Product Code
DPT  
Date Received07/06/1990
Decision Date 04/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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