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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing and support, ventilator (w harness)
510(k) Number K921510
Device Name GAS SAMPLING KIT MODIFICATION
Applicant
RESPIRATORY SUPPORT PRODUCTS, INC.
2552 MCGAW AVE.
IRVINE,  CA  92614
Applicant Contact ANTHONY V BERAN
Correspondent
RESPIRATORY SUPPORT PRODUCTS, INC.
2552 MCGAW AVE.
IRVINE,  CA  92614
Correspondent Contact ANTHONY V BERAN
Regulation Number868.5975
Classification Product Code
BZO  
Date Received03/13/1992
Decision Date 06/11/1992
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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