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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retention Device, Suture
510(k) Number K863570
Device Name LE VEEN WOUND SPLINT
Applicant
Tek-Aid, Inc.
1023 Wappoo Rd., Suite 41-B
Charleston,  SC  29407
Applicant Contact SUSAN J SMOAK
Correspondent
Tek-Aid, Inc.
1023 Wappoo Rd., Suite 41-B
Charleston,  SC  29407
Correspondent Contact SUSAN J SMOAK
Regulation Number878.4930
Classification Product Code
KGS  
Date Received09/12/1986
Decision Date 09/29/1986
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
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