DISIMETRIC RELEASE OF INSTRANETICS RAD— 510(k) K830786

Name: FDA 510(k) clearance K830786
Creator: U.S. Food and Drug Administration
Published: 1983-05-18

Substantially Equivalent

American Convertors Div., American Pharmaseal

FDA 510(k) clearance K830786 for DISIMETRIC RELEASE OF INSTRANETICS RAD, Substantially Equivalent on 1983-05-18. Applicant: American Convertors Div., American Pharmaseal. Device class: 1.

Clearance details

Applicant: American Convertors Div., American Pharmaseal
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1983-03-11
Decision date: 1983-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOA

view all

K182664 — FiXcision2018-12-07
K950267 — URETHRAL SUTURE GUIDE1995-01-31
K932465 — LI VASECTOMY1994-03-02
K921546 — VASOVASOSTOMY SET1993-07-02
K931181 — VESITEC SUTURE PASSER1993-05-12

More clearances from American Convertors Div., American Pharmaseal

view all

K840957 — ANTIMICROBIAL INCISE DRAPE1984-06-07
K832137 — CONVERTORS FLASH STERILIZING TRAY1983-08-12
K820994 — ABSORB FURN SHEET1982-05-13
K813419 — COMFORT CUSHION DRY BURN PAD III1982-01-22
K813296 — CONVERTORS STERILE DISP. LAP SPONGE II1981-12-29

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