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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 K000663
Device Name KRONNER LOW PROFILE SCOPE HOLDER
Applicant
KRONNER PROTOTYPES, INC.
1443 UPPER CLEVELAND RAPIDS RD
ROSEBURG,  OR  97470
Applicant Contact RICHARD KRONNER
Correspondent
KRONNER PROTOTYPES, INC.
1443 UPPER CLEVELAND RAPIDS RD
ROSEBURG,  OR  97470
Correspondent Contact RICHARD KRONNER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/28/2000
Decision Date 05/02/2000
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
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