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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 K954442
Device Name STERILE ISOTONIC SALINE & STERILE WATER
Applicant
Medcare Custom Packaging, Inc.
234 Old Homestead Hwy.
Rte. 32
East Swanzey,  NH  03446
Applicant Contact CRAIG J BELL
Correspondent
Medcare Custom Packaging, Inc.
234 Old Homestead Hwy.
Rte. 32
East Swanzey,  NH  03446
Correspondent Contact CRAIG J BELL
Regulation Number880.6740
Classification Product Code
JOL  
Date Received09/25/1995
Decision Date 12/21/1995
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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