FOAM CARE ONE STEP PREP— 510(k) K843636

Name: FDA 510(k) clearance K843636
Creator: U.S. Food and Drug Administration
Published: 1984-11-16

Substantially Equivalent

Ballard Medical Products

FDA 510(k) clearance K843636 for FOAM CARE ONE STEP PREP, Substantially Equivalent on 1984-11-16. Applicant: Ballard Medical Products. Device class: 1.

Clearance details

Applicant: Ballard Medical Products
Product code: Code GEC
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-09-17
Decision date: 1984-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEC

view all

K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK1997-07-07
K960621 — EXPANDACELL INSTRUMENT WIPE1996-04-01
K900691 — BIODYNE INSTRUMENT WIPES1990-03-08
K896085 — SURGI-BRUSH1989-11-08
K875033 — STERILE SCRUBBY SCRUB BRUSH1988-02-19

More clearances from Ballard Medical Products

view all

K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE2003-03-31
K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS2002-10-11
K013892 — LUTZ NEEDLE2002-07-11
K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES2000-03-28
K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT1999-10-20

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