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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, Nonmetal, Fiberoptic
510(k) Number K853257
Device Name SPECULITE DISPOSABLE VAGINAL LIGHT
Applicant
Trylon Associates, Ltd.
26214 Athena Ave.
Harbor City,  CA  90710
Applicant Contact MARTIN L LONLY
Correspondent
Trylon Associates, Ltd.
26214 Athena Ave.
Harbor City,  CA  90710
Correspondent Contact MARTIN L LONLY
Regulation Number884.4530
Classification Product Code
HIC  
Date Received08/02/1985
Decision Date 12/27/1985
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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