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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 K801791
Device Name FERTILITY AWARENESS METHOD KIT
Applicant
Telesis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Telesis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.2920
Classification Product Code
FLK  
Date Received07/29/1980
Decision Date 10/31/1980
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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