TotalShield II Surgical Helmet System— 510(k) K192194

Substantially Equivalent

Zimmer Surgical, Inc.

FDA 510(k) clearance K192194 for TotalShield II Surgical Helmet System, Substantially Equivalent on 2019-10-15. Applicant: Zimmer Surgical, Inc..

Clearance details

Applicant: Zimmer Surgical, Inc.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2019-08-13
Decision date: 2019-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Dover, OH, US

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