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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 K820641
Device Name ACCURETTE
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 Received03/08/1982
Decision Date 06/22/1982
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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