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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen
510(k) Number K781055
Device Name FACE TENTS
Applicant
Hospitak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hospitak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5580
Classification Product Code
BYG  
Date Received06/23/1978
Decision Date 07/17/1978
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
Recalls CDRH Recalls
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