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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 K942907
Device Name JEMSDAL MASK
Applicant
RESPAN PRODUCTS, INC.
VITAID, LTD
240 PORTAGE ROAD
LEWISTON,  NY  14092 -0670
Correspondent
RESPAN PRODUCTS, INC.
VITAID, LTD
240 PORTAGE ROAD
LEWISTON,  NY  14092 -0670
Regulation Number868.5580
Classification Product Code
BYG  
Date Received06/21/1994
Decision Date 08/31/1994
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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