DRAPES, MODESTY— 510(k) K770396

Substantially Equivalent

Mark One Healthcare Products

FDA 510(k) clearance K770396 for DRAPES, MODESTY, Substantially Equivalent on 1977-03-23. Applicant: Mark One Healthcare Products. Device class: 2.

Clearance details

Applicant: Mark One Healthcare Products
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1977-03-01
Decision date: 1977-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Mark One Healthcare Products

K891986 — MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE1989-12-29
K833867 — PAREMA K BAND NON-STERILE1984-01-27
K833084 — MASTERHINGE1983-10-14
K761268 — SKIN PRESSURE PROTECTORS1977-02-16

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