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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 K982151
Device Name STERITITE PROCESS INDICATOR ACCESSORIES
Applicant
Case Medical, Inc.
65 Railroad Ave.
Ridgefield,  NJ  07657 -0402
Applicant Contact MARCIA FRIEZE
Correspondent
Case Medical, Inc.
65 Railroad Ave.
Ridgefield,  NJ  07657 -0402
Correspondent Contact Tania Lupu
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received06/18/1998
Decision Date 02/09/1999
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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