Converse Altar Retractor

FDA 510(k) K760851 · V. Mueller O.V. Baxter Healthcare Corp.

Substantially Equivalent

510(k) numberK760851

Submission

Device name
Converse Altar Retractor
Applicant
V. Mueller O.V. Baxter Healthcare Corp.
Mchenry, IL, US
Received
October 15, 1976
Decision date
March 10, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KAL – Retractor, Ent
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KAL

510(k)DeviceApplicantDecision
K870758Small Mastoid RetractorKAL · Traditional Treace Medical, Inc.03/04/1987SE
K833604Adjustable Fork RetractorKAL · Traditional Microtek Medical, Inc.01/03/1984SE
K772392Allport Mastoid RetractorsKAL · Traditional Edward Weck, Inc.01/17/1978SE
K772381Ring Handle & RetractorsKAL · Traditional Edward Weck, Inc.01/17/1978SE

More from Edward Weck, Inc.

510(k)DeviceDecision
K803292Field Suction DissectorGDI · Traditional 01/29/1981SE
K792383Kelman DipstickHOE · Traditional 12/11/1979SE
K771197Norton EndotrachealBTR · Traditional 08/16/1977SE
K771302Pfister-Schwartz Stone RetrieverFGO · Traditional 08/02/1977SE
K770959Bougie, Filiform, JacksonKBI · Traditional 06/14/1977SE
K770280Cord, Electrosurgical-Sterile & Dispos.KNS · Traditional 04/15/1977SE
K761242Teflon Coated Resectoscope SheathFJL · Traditional 12/16/1976SE
K760273LithotriteFGK · Traditional 12/06/1976SE
K760189Stopcock, WaterlineFAJ · Traditional 12/02/1976SE
K760184Element, WorkingFDC · Traditional 12/02/1976SE

Questions and answers

When was Converse Altar Retractor cleared by the FDA?

Converse Altar Retractor (K760851) received a 510(k) decision of Substantially Equivalent on March 10, 1977, 146 days after the submission was received.

What is the product code of K760851?

The FDA product code is KAL – Retractor, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.