Skin Scrub Tray

FDA 510(k) K810558 · Associated Medical Products Co.

Substantially Equivalent

510(k) numberK810558

Submission

Device name
Skin Scrub Tray
Applicant
Associated Medical Products Co.
Mchenry, IL, US
Received
March 2, 1981
Decision date
March 17, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HFD – Washer, Endometrial
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1185
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFD

510(k)DeviceApplicantDecision
K891037Weighted Specula-Steiner,Henrotin,Berland,GarrigueHFD · Traditional Zinnanti Surgical Instruments, Inc.03/17/1989SE
K890376Vaginal SpeculumHFD · Traditional Kinetic Medical Products02/27/1989SE

More from Kinetic Medical Products

510(k)DeviceDecision
K932221Neurological or Crani Trays (Packs)LRO · Traditional 03/19/1997SE
K932216C-Section, Labor & Delivery Trays (Packs)MLS · Traditional 04/19/1994SESK
K930507Custom Orthopaedic Trays (Packs)HTS · Traditional 02/22/1994SE
K932217Major, Minor, Basin Trays (Packs)LRO · Traditional 11/15/1993SESK
K932220Lap Choly Trays (Packs)LRO · Traditional 09/27/1993SESK
K932218Cardiac Cath or Angiographic TraysDQO · Traditional 08/27/1993SEKD
K932219Suture Set or Laceration Trays (Packs)KDD · Traditional 07/09/1993SESK
K842983Ampco Opthalmic TrayHOZ · Traditional 05/22/1985SE
K843114Ampco Procedure Trays / Packs · Traditional 08/08/1984SESP
K823839Ampco Kidney Dialysis TrayKOC · Traditional 03/29/1983SE

Questions and answers

When was Skin Scrub Tray cleared by the FDA?

Skin Scrub Tray (K810558) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 15 days after the submission was received.

What is the product code of K810558?

The FDA product code is HFD – Washer, Endometrial, a Class II (moderate risk) device regulated under 21 CFR 884.1185.