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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Calibrator, Volume, Gas
510(k) Number K810290
Device Name OHIO CAL-CHEK
Applicant
OHIO MEDICAL PRODUCTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
OHIO MEDICAL PRODUCTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1870
Classification Product Code
BXW  
Date Received02/03/1981
Decision Date 02/12/1981
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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