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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 K782163
Device Name THE BLUE MASK
Applicant
COLLECTOVAC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COLLECTOVAC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received12/21/1978
Decision Date 03/01/1979
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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