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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Gas Generating
510(k) Number K871238
Device Name ANABAG
Applicant
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Applicant Contact PAUL CAMPOGNONE
Correspondent
Scott Laboratories, Inc.
Fiskeville,  RI  02823
Correspondent Contact PAUL CAMPOGNONE
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received03/27/1987
Decision Date 04/03/1987
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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