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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Alcohol, Device Disinfectant
510(k) Number K852235
Device Name STERETS INJECTION SWAB
Applicant
Ellis Pharmaceutical Consulting, Inc.
913 State Rd.
Princeton,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
Ellis Pharmaceutical Consulting, Inc.
913 State Rd.
Princeton,  NJ  08540
Correspondent Contact LEVI ELLIS
Classification Product Code
LKB  
Date Received05/22/1985
Decision Date 06/07/1985
Decision Substantially Equivalent (SESE)
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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