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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, Enriched
510(k) Number K850724
Device Name CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL
Applicant
Rapid City Regional Hospital, Inc.
353 Fairmont Blvd.
Rapid City,  SD  57701
Applicant Contact SHEILA M HILLBERRY
Correspondent
Rapid City Regional Hospital, Inc.
353 Fairmont Blvd.
Rapid City,  SD  57701
Correspondent Contact SHEILA M HILLBERRY
Regulation Number866.2330
Classification Product Code
KZI  
Date Received02/22/1985
Decision Date 03/25/1985
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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