Thumb Dressing Forceps 5

FDA 510(k) K821282 · Conphar, Inc.

Substantially Equivalent

510(k) numberK821282

Submission

Device name
Thumb Dressing Forceps 5
Applicant
Conphar, Inc.
Mchenry, IL, US
Received
May 3, 1982
Decision date
May 28, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EFL – Forceps, Dressing, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EFL

510(k)DeviceApplicantDecision
K890243Dressing ForcepsEFL · Traditional Kinetic Medical Products01/27/1989SE
K821778Beach Dressing PlierEFL · Traditional Pacific Dental Corp.07/06/1982SE
K821285Splinter Forceps 4 1/2EFL · Traditional Conphar, Inc.05/28/1982SE
K821284Adson Forceps 4 3/4EFL · Traditional Conphar, Inc.05/28/1982SE

More from Conphar, Inc.

510(k)DeviceDecision
K821825Conphar Silicone Feeding TubeKNT · Traditional 08/10/1982SE
K821354Conphar Mayo Hegar Needle HolderGDF · Traditional 06/03/1982SE
K821295Olsen Hegar Needle HoldersGDF · Traditional 06/03/1982SE
K821289Mayo-Hegar Needle HolderGDF · Traditional 06/03/1982SE
K821298Backhaus Clamp, 3 1/2HTD · Traditional 05/28/1982SE
K821294Tonsil Scissors Straight 5 1/2EGN · Traditional 05/28/1982SE
K821293Backhaus Clamp, 5 1/4HTD · Traditional 05/28/1982SE
K821292Tonsil Scissors 7EGN · Traditional 05/28/1982SE
K821290Littauer Scissors 5 1/2HNF · Traditional 05/28/1982SE
K821286Iris Scissors Straight 4 1/2HNF · Traditional 05/28/1982SE

Questions and answers

When was Thumb Dressing Forceps 5 cleared by the FDA?

Thumb Dressing Forceps 5 (K821282) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 25 days after the submission was received.

What is the product code of K821282?

The FDA product code is EFL – Forceps, Dressing, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.