FITTING/DIALYZER— 510(k) K760815

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K760815 for FITTING/DIALYZER, Substantially Equivalent on 1976-11-19. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FTG
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1976-10-12
Decision date: 1976-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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