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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Irrigation Solution
510(k) Number K833944
Device Name STERILE SOLUTION WARMER
Applicant
National Fabtronix, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
National Fabtronix, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5950
Classification Product Code
LHC  
Date Received11/15/1983
Decision Date 01/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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