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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, Non-Rebreathing
510(k) Number K913164
Device Name NON REBREATHING MASK
Applicant
Specialty Packaging Producs, Inc.
19 Leigh Fisher
El Paso,  TX  79906
Applicant Contact EDWARD F VALDEZ
Correspondent
Specialty Packaging Producs, Inc.
19 Leigh Fisher
El Paso,  TX  79906
Correspondent Contact EDWARD F VALDEZ
Regulation Number868.5570
Classification Product Code
KGB  
Date Received07/17/1991
Decision Date 01/15/1992
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
Recalls CDRH Recalls
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