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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K022062
Device Name IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
Applicant
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006 -0508
Applicant Contact LESLIE H SHERMAN
Correspondent
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006 -0508
Correspondent Contact LESLIE H SHERMAN
Regulation Number868.5895
Classification Product Code
MOD  
Date Received06/25/2002
Decision Date 05/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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