EPI 2— 510(k) K935706

Substantially Equivalent

Universal H.R. System, Inc.

FDA 510(k) clearance K935706 for EPI 2, Substantially Equivalent on 1997-02-11. Applicant: Universal H.R. System, Inc.. Device class: 1.

Clearance details

Applicant: Universal H.R. System, Inc.
Product code: Code KCX
Device class: Class 1
Regulation: 21 CFR 878.5360
Advisory panel: General, Plastic Surgery
Date received: 1993-11-30
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCX

K973773 — DAPELLE HAIR REMOVER1997-12-17
K973340 — TWEEZER-TYPE EPILATOR1997-12-03
K973174 — SONIQUE HAIR REMOVER1997-10-30
K973179 — FEMINIQUE SONIC HAIR REMOVER1997-10-30
K972695 — FINALLY FREE1997-10-22

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