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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Syringe
510(k) Number K200242
Device Name StaClear Syringe
Applicant
Tribofilm Research, Inc.
625 Hutton St.
Raleigh,  NC  27606
Applicant Contact Jackson Thornton
Correspondent
Namsa
400 Hwy. 169 S.
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Beryl St. Jeanne
Regulation Number880.5860
Classification Product Code
QLY  
Subsequent Product Codes
FMF   FMI  
Date Received01/31/2020
Decision Date 07/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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