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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 K880578
Device Name LAKE DISPOSABLE PROBE COVER
Applicant
Lake Medical Products, Inc.
11866 Adie Rd.
Maryland Heights,  MO  63043
Applicant Contact ELI SCHACHET
Correspondent
Lake Medical Products, Inc.
11866 Adie Rd.
Maryland Heights,  MO  63043
Correspondent Contact ELI SCHACHET
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/10/1988
Decision Date 03/31/1988
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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