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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Floor Standing
510(k) Number K980044
Device Name XENON 300MX
Applicant
PERKINELMER OPTOELECTRONICS
35 CONGRESS ST.
SALEM,  MA  01970
Applicant Contact ANTHONY STATUTO
Correspondent
PERKINELMER OPTOELECTRONICS
35 CONGRESS ST.
SALEM,  MA  01970
Correspondent Contact ANTHONY STATUTO
Regulation Number878.4580
Classification Product Code
FSS  
Date Received01/06/1998
Decision Date 04/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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