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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 K973543
Device Name KRONNER LOW PROFILE SCOPE HOLDER
Applicant
KRONNER PROTOTYPES, INC.
1443 UPPER CLEVELAND RAPIDS RD
ROSEBURG,  OR  97470
Applicant Contact CRYSTAL KRONNER
Correspondent
KRONNER PROTOTYPES, INC.
1443 UPPER CLEVELAND RAPIDS RD
ROSEBURG,  OR  97470
Correspondent Contact CRYSTAL KRONNER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/18/1997
Decision Date 01/12/1998
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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