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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Catheter
510(k) Number K854327
Device Name SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
Applicant
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number878.4200
Classification Product Code
GCB  
Date Received10/28/1985
Decision Date 11/13/1985
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
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