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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name regulator, pressure, gas cylinder
510(k) Number K780364
Device Name MANIFOLD KIT
Applicant
SPICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SPICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2700
Classification Product Code
CAN  
Date Received03/06/1978
Decision Date 03/30/1978
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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