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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 Rd.
Lewiston,  NY  14092
Correspondent
Respan Products, Inc.
Vitaid, Ltd
240 Portage Rd.
Lewiston,  NY  14092
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
Predetermined Change
Control Plan Authorized		 No
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