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510(k) K192194

TotalShield II Surgical Helmet System by Zimmer Surgical, Inc. — Product Code FYA

K192194 is an FDA 510(k) premarket notification submitted by Zimmer Surgical, Inc. for the device "TotalShield II Surgical Helmet System". The FDA issued a decision of Substantially Equivalent on October 15, 2019. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2019
Date Received
August 13, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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FDA data resources