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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mask, gas, anesthetic
510(k) Number K810990
Device Name OHIO NONCONDUCTIVE RBS TYPE FACE MASK
Applicant
OHIO MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OHIO MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received04/13/1981
Decision Date 04/23/1981
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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