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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 K910271
Device Name VACPAC PORTABLE ASPIRATION SYSTEM
Applicant
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Correspondent Contact CRAIG RAPP
Regulation Number878.4780
Classification Product Code
BTA  
Date Received01/23/1991
Decision Date 03/20/1991
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
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