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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K843796
Device Name STERILE WATER
Applicant
Paco Pharmaceutical Services, Inc.
913 State Rd.
Princeton,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
Paco Pharmaceutical Services, Inc.
913 State Rd.
Princeton,  NJ  08540
Correspondent Contact LEVI ELLIS
Date Received09/27/1984
Decision Date 12/10/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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