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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K844672
Device Name INSTRUTAINER
Applicant
Intrumed, Inc.
12522 128th Ave. NE
Kirkland,  WA  98034
Applicant Contact JERRY L SPENCE
Correspondent
Intrumed, Inc.
12522 128th Ave. NE
Kirkland,  WA  98034
Correspondent Contact JERRY L SPENCE
Regulation Number880.6850
Classification Product Code
FRG  
Date Received11/30/1984
Decision Date 02/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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