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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Cervical
510(k) Number K831669
Device Name AXCAN SPERM CUP
Applicant
Axcan Scientific Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Axcan Scientific Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.5250
Classification Product Code
HDR  
Date Received05/23/1983
Decision Date 07/12/1983
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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