TOTAL SHIELD SURGICAL +3 more— 510(k) K142166
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K142166 for TOTAL SHIELD SURGICAL +3 more, Substantially Equivalent on 2014-08-28. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Device name as filed
- TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES
- Applicant
- Zimmer, Inc.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dover, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.