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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 K802653
Device Name MEDIUM SIZE OXYGEN HOOD #1547
Applicant
Ann Arbor Plastics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ann Arbor Plastics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5700
Classification Product Code
BYL  
Date Received10/24/1980
Decision Date 11/24/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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