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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K952219
Device Name SUCTION TIP CLEANER CUP
Applicant
Moore/Gobel
9712 S. Altamont Dr.
Sandy,  UT  84092
Applicant Contact WILLIAM E MCKAY
Correspondent
Moore/Gobel
9712 S. Altamont Dr.
Sandy,  UT  84092
Correspondent Contact WILLIAM E MCKAY
Regulation Number880.6740
Classification Product Code
GCX  
Date Received05/11/1995
Decision Date 11/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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