SURGICAL DRAPES— 510(k) K943122

Substantially Equivalent

Mallinckrodt Group, Inc.

FDA 510(k) clearance K943122 for SURGICAL DRAPES, Substantially Equivalent on 1994-09-07. Applicant: Mallinckrodt Group, Inc.. Device class: 2.

Clearance details

Applicant: Mallinckrodt Group, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1994-06-29
Decision date: 1994-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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K943581 — HYDRADJUST IV UROLOGICAL TABLE1995-01-04
K934664 — HYDRAGOWN1994-05-24
K920742 — HYDRAJUST IV UROLOGICAL TABLE1992-04-27

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