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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
510(k) Number K950197
Device Name MICROCO
Applicant
Micro Direct, Inc.
P.O. Box 239
840 Pownal Rd.
Auburn,  ME  04210 -0239
Applicant Contact DAVID R STASZAK
Correspondent
Micro Direct, Inc.
P.O. Box 239
840 Pownal Rd.
Auburn,  ME  04210 -0239
Correspondent Contact DAVID R STASZAK
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received01/18/1995
Decision Date 10/17/1996
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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