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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 S. Davis Blvd.
Bountiful,  UT  84010
Applicant Contact THOMAS J HASLAM
Correspondent
Specialty Medical Products Co.
3063 S. Davis Blvd.
Bountiful,  UT  84010
Correspondent Contact THOMAS J HASLAM
Regulation Number878.4200
Classification Product Code
GBQ  
Date Received11/09/1987
Decision Date 12/02/1987
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
Predetermined Change
Control Plan Authorized		 No
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