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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, nephrostomy, general & plastic surgery
510(k) Number K854911
Device Name PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
Applicant
ANGIOMED U.S., INC.
4081 EAST LA PALMA AVE.,
SUITE E
ANAHEIM,  CA  92807
Applicant Contact RICHARD P MOHR
Correspondent
ANGIOMED U.S., INC.
4081 EAST LA PALMA AVE.,
SUITE E
ANAHEIM,  CA  92807
Correspondent Contact RICHARD P MOHR
Regulation Number878.4200
Classification Product Code
GBO  
Date Received12/09/1985
Decision Date 01/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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