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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K190541
Device Name MTS225 and MTS300 Multiple Tray Sterilization Systems
Applicant
PMBS, LLC
5419 Delette Avenue South
St. Petersburg,  FL  33707
Applicant Contact Michele E. Mauzerall
Correspondent
Hillring & Associates, Inc
3012 St. Charles Drive
Tampa,  FL  33618
Correspondent Contact Annette M. Hillring
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/04/2019
Decision Date 11/05/2019
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
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