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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K925588
Device Name NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
Applicant
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Applicant Contact CHARLES E MEISCH
Correspondent
North American Sterilization & Packaging Co.
15 White Lake Rd.
P.O. Box 923
Sparta,  NJ  07871
Correspondent Contact CHARLES E MEISCH
Classification Product Code
LDQ
Date Received11/05/1992
Decision Date 12/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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