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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K864683
Device Name NEONATAL FEEDING KIT
Applicant
SALT CREEK MEDICAL TECHNOLOGIES
5500 ARAPAHO PASS
PINCKNEY,  MI  48169
Applicant Contact HOWARD MEADE
Correspondent
SALT CREEK MEDICAL TECHNOLOGIES
5500 ARAPAHO PASS
PINCKNEY,  MI  48169
Correspondent Contact HOWARD MEADE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/02/1986
Decision Date 04/17/1987
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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