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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Factor Xiii A, S, Antigen, Antiserum, Control
510(k) Number K872230
Device Name MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Applicant Contact KEN BISHOP
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Correspondent Contact KEN BISHOP
Regulation Number866.5330
Classification Product Code
DBT  
Date Received06/09/1987
Decision Date 09/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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