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
- Product 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
Recent devices under product code FYA
view all- K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
More clearances from Zimmer, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.