H.R. JAKOBI SURG. INSTRUMENTS #4 30/31— 510(k) K834177

Name: FDA 510(k) clearance K834177
Creator: U.S. Food and Drug Administration
Published: 1983-12-27

Substantially Equivalent

Imm Enterprises , Ltd.

FDA 510(k) clearance K834177 for H.R. JAKOBI SURG. INSTRUMENTS #4 30/31, Substantially Equivalent on 1983-12-27. Applicant: Imm Enterprises , Ltd.. Device class: 1.

Clearance details

Applicant: Imm Enterprises , Ltd.
Product code: Code HGE
Device class: Class 1
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1983-11-21
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGE

view all

K951148 — OBSTI-HOOK1995-06-09
K926425 — AMNIPERF(TM)1994-03-07
K910518 — GLOVE-N-GEL AMNIOTOMY KIT1991-05-09
K871087 — S.C.M.T. PERFORATOR1987-03-23
K850758 — AMNIGLOVE & AMNICOT1985-04-15

More clearances from Imm Enterprises , Ltd.

view all

K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES1984-05-09
K841386 — KOLLMANN URETHRAL DILATOR1984-05-09
K841387 — WESTON RECTAL SNARE1984-05-09
K840304 — CATEGORY 17-MICROBIOLOGY DEVICES1984-05-01
K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE1984-04-23

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