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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
Predetermined Change
Control Plan Authorized		 No
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