K142166

Substantially Equivalent

TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES

Applicant: Zimmer, Inc.
Product code: FYA
Advisory panel: General, Plastic Surgery
Date received: 2014-07-30
Decision date: 2014-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Dover, OH, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.