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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K902161
Device Name DEMISTIFIER ISOLATION CHAMBER
Applicant
Peace Medical, Inc.
50 S.Center St.
Suite 11
Orange,  NJ  07050
Applicant Contact KEVIN FEGAN
Correspondent
Peace Medical, Inc.
50 S.Center St.
Suite 11
Orange,  NJ  07050
Correspondent Contact KEVIN FEGAN
Regulation Number868.5430
Classification Product Code
CBN  
Date Received05/15/1990
Decision Date 10/15/1990
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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