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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, hysteroscopic
510(k) Number K894259
Device Name REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
Applicant
WASHINGTON REGULATORY SERVICES
R.D. # 3 BOX 237
WELISEWITZ RD.
RINGOES,  NJ  08551
Applicant Contact RANDOLPH COOKE
Correspondent
WASHINGTON REGULATORY SERVICES
R.D. # 3 BOX 237
WELISEWITZ RD.
RINGOES,  NJ  08551
Correspondent Contact RANDOLPH COOKE
Regulation Number884.1700
Classification Product Code
HIG  
Date Received06/20/1989
Decision Date 03/05/1990
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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