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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stand, Infusion
510(k) Number K854082
Device Name PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD
Applicant
Gray Wave Corp.
27272 Cool Water Ranch Rd.
Valley Center,  CA  92082
Applicant Contact MYRON NORENBERT
Correspondent
Gray Wave Corp.
27272 Cool Water Ranch Rd.
Valley Center,  CA  92082
Correspondent Contact MYRON NORENBERT
Regulation Number880.6990
Classification Product Code
FOX  
Date Received10/07/1985
Decision Date 11/01/1985
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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