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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K052286
Device Name DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
Applicant
THE CATHETER EXCHANGE, INC.
16633 VENTURA BLVD.
SUITE 735
ENCINO,  CA  91436
Applicant Contact GEORGE P TEITELBAUM
Correspondent
THE CATHETER EXCHANGE, INC.
16633 VENTURA BLVD.
SUITE 735
ENCINO,  CA  91436
Correspondent Contact GEORGE P TEITELBAUM
Regulation Number878.4200
Classification Product Code
GBX  
Date Received08/22/2005
Decision Date 10/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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