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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen, Sterile
510(k) Number K790915
Device Name JUHN TYM-TAP
Applicant
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Correspondent
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Regulation Number864.3250
Classification Product Code
FMH  
Date Received05/14/1979
Decision Date 06/27/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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