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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 K943661
Device Name STERILE PHYSIOLOGICAL SALINE/STERILE WATER
Applicant
Medcare Custom Packaging, Inc.
Winchester St.
E Swanzey,  NH  03469
Applicant Contact WILLIAM A HAYS
Correspondent
Medcare Custom Packaging, Inc.
Winchester St.
E Swanzey,  NH  03469
Correspondent Contact WILLIAM A HAYS
Regulation Number880.6740
Classification Product Code
JOL  
Date Received07/28/1994
Decision Date 04/10/1995
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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