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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K203461
Device Name Aesculap Caiman 12 Seal and Cut Technology System
Applicant
Aesculap Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Omunique Luke
Correspondent
Aesculap Inc.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Omunique Luke
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/24/2020
Decision Date 12/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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