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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K862569
Device Name HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
Applicant
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Applicant Contact CRAIG RAPP
Correspondent
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Correspondent Contact CRAIG RAPP
Regulation Number878.4780
Classification Product Code
BTA  
Date Received07/07/1986
Decision Date 08/14/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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