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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nasal, Oxygen
510(k) Number K843466
Device Name PHARMA-PLAST OXYGEN CATHETER
Applicant
Zimmar Consulting , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact DOUGLASS M BENNETT
Correspondent
Zimmar Consulting , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact DOUGLASS M BENNETT
Regulation Number868.5350
Classification Product Code
BZB  
Date Received09/06/1984
Decision Date 11/19/1984
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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