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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Nasal, Oxygen
510(k) Number K884149
Device Name COMFORT STRAP
Applicant
COMFORT STRAP CO.
212 SECOND AVE EAST
EGAN,  SD  57024 -9701
Applicant Contact ROD CLARK
Correspondent
COMFORT STRAP CO.
212 SECOND AVE EAST
EGAN,  SD  57024 -9701
Correspondent Contact ROD CLARK
Regulation Number868.5340
Classification Product Code
CAT  
Date Received10/03/1988
Decision Date 10/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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