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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K911760
Device Name MONARCH STERILIZATION CONTAINER SYST, MODIFICATION
Applicant
Monarch Products, Inc.
P.O. Box 1899
Jacksonville,  TX  75766
Applicant Contact RODNEY D CONSTANT
Correspondent
Monarch Products, Inc.
P.O. Box 1899
Jacksonville,  TX  75766
Correspondent Contact RODNEY D CONSTANT
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/12/1991
Decision Date 06/24/1991
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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