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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 K932138
Device Name SALINE FOR IRRIGATION
Applicant
Rantran, Inc.
2624 Beaver Glen Dr.
Ashland,  VA  23005
Applicant Contact ED RANSOM
Correspondent
Rantran, Inc.
2624 Beaver Glen Dr.
Ashland,  VA  23005
Correspondent Contact ED RANSOM
Regulation Number880.6740
Classification Product Code
JOL  
Date Received04/21/1993
Decision Date 11/04/1994
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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