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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Incubators/Water, All
510(k) Number K853379
Device Name PLATE INCUBATOR
Applicant
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Applicant Contact NICOLAS SCHMELZER
Correspondent
Scientific Sales Intl., Inc.
P.O. Box 1538
Kalamazoo,  MI  49005
Correspondent Contact NICOLAS SCHMELZER
Regulation Number866.2540
Classification Product Code
JTQ  
Date Received08/12/1985
Decision Date 09/03/1985
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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