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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 K790659
Device Name INFANT SCALE DISPOSABLE LINER
Applicant
Hydro-Med Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hydro-Med Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6060
Classification Product Code
KME  
Date Received04/04/1979
Decision Date 04/30/1979
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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