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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K971546
Device Name SOMA 900 TRANSPORT BED
Applicant
Nova Technologies, Inc.
545 Middle St.
Bristol,  CT  06010
Applicant Contact SAMUEL N PAUL
Correspondent
Nova Technologies, Inc.
545 Middle St.
Bristol,  CT  06010
Correspondent Contact SAMUEL N PAUL
Regulation Number880.5100
Classification Product Code
FNL  
Date Received04/28/1997
Decision Date 07/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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