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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K890072
Device Name PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
Applicant
Medireach, Inc.
4885 Alpha Rd.
Suite #155
Dallas,  TX  75244
Applicant Contact L WASHINGTON
Correspondent
Medireach, Inc.
4885 Alpha Rd.
Suite #155
Dallas,  TX  75244
Correspondent Contact L WASHINGTON
Regulation Number876.5130
Classification Product Code
KNY  
Date Received01/09/1989
Decision Date 06/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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