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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K964723
Device Name RACAL N95 RESIRATOR
Applicant
Racal Filter Technologies, Inc.
1360 California Ave.
P.O. Box 665
Brockville, Ontario,  CA K6V 5V8
Applicant Contact JOHN CAMPBELL
Correspondent
Racal Filter Technologies, Inc.
1360 California Ave.
P.O. Box 665
Brockville, Ontario,  CA K6V 5V8
Correspondent Contact JOHN CAMPBELL
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/25/1996
Decision Date 02/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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