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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K931048
Device Name 4-SURE NELATON CATHETER
Applicant
BOSTON PACIFIC MEDICAL, INC.
451 D ST.
SUITE 811
BOSTON,  MA  02210
Applicant Contact HOWARD HUTCHINSON
Correspondent
BOSTON PACIFIC MEDICAL, INC.
451 D ST.
SUITE 811
BOSTON,  MA  02210
Correspondent Contact HOWARD HUTCHINSON
Regulation Number876.5130
Classification Product Code
EZD  
Date Received03/01/1993
Decision Date 02/14/1994
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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