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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 K895039
Device Name STERILE SALINE - FOR SUCTION CATHETER LUBRICATION
Applicant
Aplicare, Inc.
7 Orchard Park Rd.
Madison,  CT  06443
Applicant Contact PAUL G BUCCETTI
Correspondent
Aplicare, Inc.
7 Orchard Park Rd.
Madison,  CT  06443
Correspondent Contact PAUL G BUCCETTI
Regulation Number880.6740
Classification Product Code
GCX  
Date Received08/09/1989
Decision Date 10/03/1989
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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