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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K924809
Device Name IRRIGATION TRAY W/ BULB SYRINGE
Applicant
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Applicant Contact FELIX B SANTOS
Correspondent
CUSTOMED, INC.
CALLE IGUALDAD #7
FAJARDO,  PR  00738
Correspondent Contact FELIX B SANTOS
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received09/24/1992
Decision Date 06/07/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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