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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anastomotic, Microvascular
510(k) Number K861985
Device Name 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
Applicant
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Applicant Contact CHARLES W OPP
Correspondent
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Correspondent Contact CHARLES W OPP
Regulation Number878.4300
Classification Product Code
MVR  
Date Received05/22/1986
Decision Date 12/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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