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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 K193587
Device Name Sutter Swyng non-stick bipolar forceps, single-use
Applicant
Sutter Medizintechnik GmbH
Tullastrasse 87
Freiburg,  DE 79108
Applicant Contact Ulrike Zeissler
Correspondent
Sutter Medizintechnik GmbH
Tullastrasse 87
Freiburg,  DE 79108
Correspondent Contact Ulrike Zeissler
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/2019
Decision Date 02/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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