AMNIPERF(TM)— 510(k) K926425

Substantially Equivalent

Raymart Development Co.

FDA 510(k) clearance K926425 for AMNIPERF(TM), Substantially Equivalent on 1994-03-07. Applicant: Raymart Development Co.. Device class: 1.

Clearance details

Applicant: Raymart Development Co.
Product code: Code HGE
Device class: Class 1
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1992-12-23
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGE

K951148 — OBSTI-HOOK1995-06-09
K910518 — GLOVE-N-GEL AMNIOTOMY KIT1991-05-09
K871087 — S.C.M.T. PERFORATOR1987-03-23
K850758 — AMNIGLOVE & AMNICOT1985-04-15
K834177 — H.R. JAKOBI SURG. INSTRUMENTS #4 30/311983-12-27

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