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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K852014
Device Name EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
Applicant
Effner and Spreine Co.
P.O. Box 191
Port Washington,  NY  11050
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Effner and Spreine Co.
P.O. Box 191
Port Washington,  NY  11050
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number876.4730
Classification Product Code
KOA  
Date Received05/09/1985
Decision Date 08/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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