PURITAN FOAM TIP SWAB MODEL 2197— 510(k) K961934

Name: FDA 510(k) clearance K961934
Creator: U.S. Food and Drug Administration
Published: 1996-07-09

Substantially Equivalent

Hardwood Products Co., LP

FDA 510(k) clearance K961934 for PURITAN FOAM TIP SWAB MODEL 2197, Substantially Equivalent on 1996-07-09. Applicant: Hardwood Products Co., LP. Device class: 2.

Clearance details

Applicant: Hardwood Products Co., LP
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1996-05-17
Decision date: 1996-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilford, ME, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHT

view all

K182049 — exCellerator Cervical Collection Device2019-04-25
K153128 — Kolplast Cervical Sample Collection Kit2017-01-13
K141057 — DISPOSABLE CERVICAL BRUSH2015-05-14
K111681 — HISTOBRUSH2012-01-19
K083012 — PAPCONE2009-04-09

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