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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K873563
Device Name APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY
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
JOL  
Date Received09/02/1987
Decision Date 11/23/1987
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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