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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K182831
Device Name SabreLine and SabreGuard Laser Fibers
Applicant
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Cori Ragan
Correspondent
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Correspondent Contact Cori Ragan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/09/2018
Decision Date 12/10/2018
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
Predetermined Change
Control Plan Authorized		 No
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