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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name valve, non-rebreathing
510(k) Number K884543
Device Name LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
Applicant
SECHRIST INDUSTRIES, INC.
2820 GRETTA LN.
ANAHEIM,  CA  92806
Applicant Contact SANDRA L DAVIS
Correspondent
SECHRIST INDUSTRIES, INC.
2820 GRETTA LN.
ANAHEIM,  CA  92806
Correspondent Contact SANDRA L DAVIS
Regulation Number868.5870
Classification Product Code
CBP  
Date Received10/31/1988
Decision Date 12/13/1988
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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