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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous irrigation
510(K) Number K874596
Device Name PERFORATED SOAKING TUBE
Applicant
SPECIALTY MEDICAL PRODUCTS CO.
3063 south davis blvd.
bountiful,  UT  84010
Contact thomas j haslam
Regulation Number878.4200
Classification Product Code
GBQ  
Date Received11/09/1987
Decision Date 12/02/1987
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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