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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Metal, Fiberoptic
510(k) Number K864865
Device Name SPECULUM, VAGINAL, METAL FIBEROPTIC
Applicant
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Applicant Contact THOMAS WILK
Correspondent
Luxtec Corp.
P.O. Box 225, Rte. 20/49
Techno Park Rd.
Sturbridge,  MA  01566
Correspondent Contact THOMAS WILK
Regulation Number884.4520
Classification Product Code
HDG  
Date Received12/11/1986
Decision Date 01/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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