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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Loupe, Diagnostic/Surgical
510(k) Number K895248
Device Name IMS5000 ILLUMINATED LOUPES
Applicant
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Applicant Contact BRUCE K PACKARD
Correspondent
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Correspondent Contact BRUCE K PACKARD
Regulation Number878.4800
Classification Product Code
FSP  
Date Received08/21/1989
Decision Date 09/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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