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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
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