SAVE-T-BREATH AMBILICAL CORD CLAMP— 510(k) K933763

Name: FDA 510(k) clearance K933763
Creator: U.S. Food and Drug Administration
Published: 1994-08-29

Substantially Equivalent

Save-T-Breath Distributors C.C.

FDA 510(k) clearance K933763 for SAVE-T-BREATH AMBILICAL CORD CLAMP, Substantially Equivalent on 1994-08-29. Applicant: Save-T-Breath Distributors C.C.. Device class: 2.

Clearance details

Applicant: Save-T-Breath Distributors C.C.
Product code: Code HFW
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1993-08-03
Decision date: 1994-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Africa, ZA

Download summary PDF View on FDA.gov ↗

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K933762 — STB YANKAUER SUCKER/NOZZLE1994-07-19
K933760 — STB GUEDEL AIRWAY1994-03-23

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