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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K864188
Device Name E-Z HOLD WITH ADHESIVE BASE.-#4065
Applicant
John F. Greer Co., Inc.
530 E. 12th St.
Oakland,  CA  94606
Applicant Contact LELAND H GREER
Correspondent
John F. Greer Co., Inc.
530 E. 12th St.
Oakland,  CA  94606
Correspondent Contact LELAND H GREER
Regulation Number876.5250
Classification Product Code
KNX  
Date Received10/27/1986
Decision Date 12/04/1986
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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