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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K863818
Device Name PM-100 THERMOGRAPH MARK 1026
Applicant
Clearwater Computer Center, Inc.
3447 Us. Hwy. 19 N.
Clearwater,  FL  34621
Applicant Contact GRAHAM C ROCKLEY
Correspondent
Clearwater Computer Center, Inc.
3447 Us. Hwy. 19 N.
Clearwater,  FL  34621
Correspondent Contact GRAHAM C ROCKLEY
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received09/30/1986
Decision Date 04/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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