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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, General Purpose, Microbiology, Diagnostic
510(k) Number K864249
Device Name NORMAL SALINE STERILE
Applicant
Mds Laboratories, Inc.
2200 S. Sheridan Way
Mississauga, Ont.
L5j 2m4,  CA
Applicant Contact WILLIAM GASTLE
Correspondent
Mds Laboratories, Inc.
2200 S. Sheridan Way
Mississauga, Ont.
L5j 2m4,  CA
Correspondent Contact WILLIAM GASTLE
Regulation Number866.2660
Classification Product Code
LIB  
Date Received10/28/1986
Decision Date 03/31/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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