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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bag, urine collection, leg, for external use, sterile
510(k) Number K780190
Device Name CATHETER STRAP & RUINARY BAY HOLDER
Applicant
BAKA MANUFACTURING CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BAKA MANUFACTURING CO., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received02/06/1978
Decision Date 02/21/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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