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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K811270
Device Name SCOPE MASTER
Applicant
SYNEMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SYNEMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/06/1981
Decision Date 09/08/1981
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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