PDI SURGICAL SCRUB SPONGE-BRUSH-T15070— 510(k) K810337

Name: FDA 510(k) clearance K810337
Creator: U.S. Food and Drug Administration
Published: 1981-02-26

Substantially Equivalent

Nice-Pak Products, Inc.

FDA 510(k) clearance K810337 for PDI SURGICAL SCRUB SPONGE-BRUSH-T15070, Substantially Equivalent on 1981-02-26. Applicant: Nice-Pak Products, Inc.. Device class: 1.

Clearance details

Applicant: Nice-Pak Products, Inc.
Product code: Code GEC
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1981-02-09
Decision date: 1981-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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 Nice-Pak Products, Inc.

view all

K974768 — PDI STERILE LUBRICATING JELLY1998-01-16
K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT1984-03-27
K840343 — PDI PREPMASTER WET PACK VAGINAL-X214771984-03-27
K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE1984-03-26
K833549 — PDI SURGICAL SCRUB/BRUSH T150-701983-11-28

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