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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K946225
Device Name 3M FILTRETE(TM) AIR FILTER MEDIA
Applicant
Tagg Industries
23210 Del Lago
Laguna Hills,  CA  92653
Applicant Contact TERRY L SHIRLEY
Correspondent
Tagg Industries
23210 Del Lago
Laguna Hills,  CA  92653
Correspondent Contact TERRY L SHIRLEY
Regulation Number868.5870
Classification Product Code
CBP  
Date Received12/12/1994
Decision Date 05/25/1995
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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