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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 K864451
Device Name UV VISIBLE SPECTROPHOTOMETERS
Applicant
Trans-National Trade Development Corp.
2 Dag Hammarskjold Plz.
866 Second Ave.
New York,  NY  10017
Applicant Contact ROBERT KELLER
Correspondent
Trans-National Trade Development Corp.
2 Dag Hammarskjold Plz.
866 Second Ave.
New York,  NY  10017
Correspondent Contact ROBERT KELLER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received11/12/1986
Decision Date 02/06/1987
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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