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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K920914
Device Name MP/S SINGLE WAVELENGTH MINI PHOTOMETER
Applicant
Artel, Inc.
12 Depot St.
Windham,  ME  04062
Applicant Contact CHARLES EWING
Correspondent
Artel, Inc.
12 Depot St.
Windham,  ME  04062
Correspondent Contact CHARLES EWING
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received02/27/1992
Decision Date 03/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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