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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Gynecological
510(k) Number K820519
Device Name BIOPSER
Applicant
ADVANCED BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ADVANCED BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4530
Classification Product Code
HFB  
Date Received02/25/1982
Decision Date 04/29/1982
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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