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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K020612
Device Name SULTAN SPOROX TEST VIAL, MODEL 75195
Applicant
Sultan Chemists, Inc.
85 W. Forest Ave.
Englewood,  NJ  07631
Applicant Contact CLARK SMITH
Correspondent
Sultan Chemists, Inc.
85 W. Forest Ave.
Englewood,  NJ  07631
Correspondent Contact CLARK SMITH
Regulation Number880.2800
Classification Product Code
JOJ  
Subsequent Product Code
MED  
Date Received02/25/2002
Decision Date 05/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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