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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K930930
Device Name COAST MEDICAL, INC. RECTAL PROBE
Applicant
Coast Medical Corp.
1060 N. Batavia
Unit H
Orange,  CA  92667
Applicant Contact DOUGLAS MONGEON
Correspondent
Coast Medical Corp.
1060 N. Batavia
Unit H
Orange,  CA  92667
Correspondent Contact DOUGLAS MONGEON
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/23/1993
Decision Date 02/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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