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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K010035
Device Name IVS TUNNELLER
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
norwalk,  CT  06856
Applicant Contact chester mccoy
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
norwalk,  CT  06856
Correspondent Contact chester mccoy
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/04/2001
Decision Date 04/04/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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