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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 K820582
Device Name 3M THINSULATE DISPOSABLE HOSPITAL BED
Applicant
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent
3M Company
2724 S. Peck Rd.
Monrovia,  CA  91016
Regulation Number880.6060
Classification Product Code
KME  
Date Received03/04/1982
Decision Date 03/18/1982
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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