STERILE DRESSING PACK— 510(k) K800490

Substantially Equivalent

Medi-Spec

FDA 510(k) clearance K800490 for STERILE DRESSING PACK, Substantially Equivalent on 1980-03-12. Applicant: Medi-Spec. Device class: 2.

Clearance details

Applicant: Medi-Spec
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1980-03-04
Decision date: 1980-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
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 Medi-Spec

K833068 — LAMINARIA JAPONICA CERVICAL DILATOR1984-02-04
K812694 — WHISK-R1981-10-26
K812426 — UTERINE ASPIRATION CURETTES(RIGID&FLEX)1981-10-08
K801554 — STERILE CAST PADDING1980-08-04
K800404 — MEDSPEC OPERATIVE OPTHALMIC KIT1980-04-24

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