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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Menstrual, Reusable
510(k) Number K010986
Device Name LUNAPADS
Applicant
Lunapads International Products, Ltd.
207 W. 6th Ave.
Vancouver Bc,  CA V5Y 1K7
Applicant Contact SUZANNE SIEMENS
Correspondent
Lunapads International Products, Ltd.
207 W. 6th Ave.
Vancouver Bc,  CA V5Y 1K7
Correspondent Contact SUZANNE SIEMENS
Regulation Number884.5435
Classification Product Code
NUQ  
Date Received04/02/2001
Decision Date 06/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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