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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen
510(k) Number K890193
Device Name SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
Applicant
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Applicant Contact MARSHALL SMITH
Correspondent
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Correspondent Contact MARSHALL SMITH
Regulation Number868.5580
Classification Product Code
BYG  
Date Received01/18/1989
Decision Date 03/14/1989
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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