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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tent, Oxygen
510(k) Number K895866
Device Name DIRD INGANT O2 (BIO 2 HOOD)
Applicant
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact W. C BENTINCK
Correspondent
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact W. C BENTINCK
Regulation Number868.5700
Classification Product Code
BYL  
Date Received10/04/1989
Decision Date 10/27/1989
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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