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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K901790
Device Name THERMOMETER, MERCURY/CLINICAL
Applicant
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Applicant Contact S. K KANWAR
Correspondent
Perlink USA, Inc.
290 Stulyvesant Ave.
Rye,  NY  10580
Correspondent Contact S. K KANWAR
Regulation Number880.2920
Classification Product Code
FLK  
Date Received04/19/1990
Decision Date 07/11/1990
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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