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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspirator, endometrial
510(k) Number K831212
Device Name ENDOSCANN
Applicant
AXCAN SCIENTIFIC CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AXCAN SCIENTIFIC CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.1060
Classification Product Code
HFF  
Date Received04/14/1983
Decision Date 06/15/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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