CPR EYE TRAY— 510(k) K960242

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960242 for CPR EYE TRAY, Substantially Equivalent on 1996-03-12. Applicant: Custom Pack Reliability. Device class: 2.

Clearance details

Applicant: Custom Pack Reliability
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1996-01-16
Decision date: 1996-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Custom Pack Reliability

K960205 — CPR TRACHEOTOMY CARE TRAY1996-08-27
K960239 — CPR D & C TRAY1996-05-23
K960243 — CPR C-SECTION DELIVERY PACK1996-05-23
K960216 — CPR SUCTION CATHETER KIT1996-04-15
K960206 — CPR DRESSING CHANGE TRAY1996-04-12

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