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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K894927
Device Name SURGI SQUEEZ
Applicant
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Applicant Contact JOHN YOUNG
Correspondent
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Correspondent Contact JOHN YOUNG
Regulation Number880.5420
Classification Product Code
KZD  
Date Received08/02/1989
Decision Date 09/11/1989
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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