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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 K885244
Device Name SAF FECAL COLLECTION KIT
Applicant
Precision Biologicals, Inc.
11a Pettipas Dr.
Dartmouth,  CA NS B3B 1K1
Applicant Contact TONY BEBBINGTON
Correspondent
Precision Biologicals, Inc.
11a Pettipas Dr.
Dartmouth,  CA NS B3B 1K1
Correspondent Contact TONY BEBBINGTON
Regulation Number866.2390
Classification Product Code
JSM  
Date Received12/22/1988
Decision Date 03/21/1989
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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