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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, metal
510(k) Number K014200
Device Name OPTIMESH
Applicant
SPINEOLOGY, INC.
1815 NORTHWESTERN AVE.
STILLWATER,  MN  55082
Applicant Contact PAMELA R SNYDER
Correspondent
SPINEOLOGY, INC.
1815 NORTHWESTERN AVE.
STILLWATER,  MN  55082
Correspondent Contact PAMELA R SNYDER
Regulation Number878.3300
Classification Product Code
EZX  
Date Received12/21/2001
Decision Date 11/26/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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