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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K933416
Device Name DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH
Applicant
Devmed Corp.
P.O. Box 30716
Palm Beach Gardens,  FL  33420
Applicant Contact GREGORY WILITA
Correspondent
Devmed Corp.
P.O. Box 30716
Palm Beach Gardens,  FL  33420
Correspondent Contact GREGORY WILITA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/12/1993
Decision Date 08/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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