ISOTONIC DILUENT— 510(k) K781008

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K781008 for ISOTONIC DILUENT, Substantially Equivalent on 1978-06-28. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1978-06-19
Decision date: 1978-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06

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