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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 K964334
Device Name EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
Applicant
Shippert Medical Technologies Corp.
7002 S. Revere Pkwy.
Suite 60
Englewood,  CO  80112
Applicant Contact SARAH MAXWELL LAKE
Correspondent
Shippert Medical Technologies Corp.
7002 S. Revere Pkwy.
Suite 60
Englewood,  CO  80112
Correspondent Contact SARAH MAXWELL LAKE
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received10/31/1996
Decision Date 12/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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