Imsi/Metripond Hand Operating Table

FDA 510(k) K830339 · Intl. Management Services, Inc.

Substantially Equivalent

510(k) numberK830339

Submission

Device name
Imsi/Metripond Hand Operating Table
Applicant
Intl. Management Services, Inc.
Mchenry, IL, US
Received
February 1, 1983
Decision date
April 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FSE – Table, Operating-Room, Manual
Device class
Class I (low risk)
Regulation
21 CFR 878.4950
Specialty
General, Plastic Surgery

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K831042Chemonucleolysis Table ExtensionFSE · Traditional Orthopedic Systems, Inc.05/16/1983SE
K822427Self-Contained Mobile Ophthal. Oper. .FSE · Traditional Surgi-Quip Inc.U09/14/1982SE
K821924Table, Operating, Field 6530-00-709-8155FSE · Traditional Emerson-Sack-Warner Corp.07/13/1982SE
K801382Disposable Surgical Head SupportFSE · Traditional Innovative Surgical Products, Inc.06/26/1980SE
K782092Armboard Cver, DisposableFSE · Traditional Anago, Inc.01/10/1979SE
K780868Chest RollsFSE · Traditional Devon Industries, Inc.08/14/1978SE
K780867Pad Holder KitFSE · Traditional Devon Industries, Inc.08/14/1978SE

More from Devon Industries, Inc.

510(k)DeviceDecision
K873612Imsi, Vital CallIQA · Traditional 11/23/1987SE
K872876Imsi/Easy Float MattressFOH · Traditional 10/13/1987SE
K843370Imsi/Metripond Gripper PlateHRS · Traditional 01/23/1985SE

Questions and answers

When was Imsi/Metripond Hand Operating Table cleared by the FDA?

Imsi/Metripond Hand Operating Table (K830339) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 70 days after the submission was received.

What is the product code of K830339?

The FDA product code is FSE – Table, Operating-Room, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.