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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K841909
Device Name VAGINAL SPECULUM - DISPOSABLE
Applicant
GALENICA ENTERPRISES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GALENICA ENTERPRISES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4530
Classification Product Code
HIB  
Date Received05/09/1984
Decision Date 07/31/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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