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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K910180
Device Name BACTI-SWAB
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact ANN SILVIUS
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact ANN SILVIUS
Regulation Number866.2390
Classification Product Code
JSM  
Date Received01/15/1991
Decision Date 05/10/1991
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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