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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 K962763
Device Name 2000 MODULAR THIRTY-NINE
Applicant
Equi-Tron Mfg., Inc.
820 Nipissing Rd., Units 3 & 4
Milton, Ontario,  CA L9T 4Z9
Applicant Contact JAMES H ALEXANDER
Correspondent
Equi-Tron Mfg., Inc.
820 Nipissing Rd., Units 3 & 4
Milton, Ontario,  CA L9T 4Z9
Correspondent Contact JAMES H ALEXANDER
Regulation Number880.5100
Classification Product Code
FNL  
Date Received07/16/1996
Decision Date 10/07/1996
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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