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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K861272
Device Name IMPACT MODELS 701, 702 AND 703
Applicant
Impact Instrumentation, Inc.
P.O. Box 412
Bogota,  NJ  07603
Applicant Contact LESLIE H SHERMAN
Correspondent
Impact Instrumentation, Inc.
P.O. Box 412
Bogota,  NJ  07603
Correspondent Contact LESLIE H SHERMAN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received04/04/1986
Decision Date 05/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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