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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K901509
Device Name TRAUMA SLEEVE
Applicant
Haz-Med, Inc.
233 Felch St.
Holland,  MI  49424
Applicant Contact DAVID B WEEKS
Correspondent
Haz-Med, Inc.
233 Felch St.
Holland,  MI  49424
Correspondent Contact DAVID B WEEKS
Regulation Number880.6060
Classification Product Code
KME  
Date Received03/30/1990
Decision Date 09/12/1990
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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