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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Manual
510(k) Number K881725
Device Name ENVIROTENT (BED)
Applicant
Envirotents, Inc.
1550 S. Pearl St., #210-D
Denver,  CO  80210
Applicant Contact C POWERS
Correspondent
Envirotents, Inc.
1550 S. Pearl St., #210-D
Denver,  CO  80210
Correspondent Contact C POWERS
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received04/22/1988
Decision Date 11/08/1988
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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