NEOCATH 1000 W/HEPCOTE— 510(k) K832793

Substantially Equivalent

Orange Medical Instruments, Inc.

FDA 510(k) clearance K832793 for NEOCATH 1000 W/HEPCOTE, Substantially Equivalent on 1983-09-26. Applicant: Orange Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant
Orange Medical Instruments, Inc.
Product code
Code CCE
Device class
Class 2
Regulation
21 CFR 868.1200
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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