SRI LP DRAPE— 510(k) K080796

Substantially Equivalent

Sri/Surgical Express

FDA 510(k) clearance K080796 for SRI LP DRAPE, Substantially Equivalent on 2008-11-17. Applicant: Sri/Surgical Express. Device class: 2.

Clearance details

Applicant: Sri/Surgical Express
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2008-03-20
Decision date: 2008-11-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Sri/Surgical Express

K080707 — SRI PLR GOWN2008-11-13

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