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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K844809
Device Name CONTINUOUS VENTILATOR
Applicant
HAMILTON MEDICAL, INC.
P.O. BOX 30008
RENO,  NV  89520
Applicant Contact GJERDE, MBA
Correspondent
HAMILTON MEDICAL, INC.
P.O. BOX 30008
RENO,  NV  89520
Correspondent Contact GJERDE, MBA
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/27/1984
Decision Date 06/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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