Malis Surgical Loupes

FDA 510(k) K874845 · Valley Forge Scientific Corp.

Substantially Equivalent

510(k) numberK874845

Submission

Device name
Malis Surgical Loupes
Applicant
Valley Forge Scientific Corp.
Valley Forge, PA, US
Received
November 24, 1987
Decision date
December 23, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HJH – Loupe, Binocular, Low Power
Device class
Class I (low risk)
Regulation
21 CFR 886.5120
Specialty
Ophthalmic

Other 510(k)s with product code HJH

510(k)DeviceApplicantDecision
K863983Exeter Operating LoupeHJH · Traditional Exeter Instruments, Inc.11/10/1986SE
K830878Binocular LoupeHJH · Traditional Almore Intl., Inc.04/06/1983SE

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K982229Bi-DentEKZ · Traditional 08/13/1998SE
K973554Valley Forge Bipolar Ball Tip ElectrodeJOS · Traditional 12/19/1997SE
K971986Valley Forge Bipolar LoopHGI · Traditional 08/26/1997SE
K964143Mini-Symm Bipolar CoagulatorGEI · Traditional 01/09/1997SE
K955764Valley Forge Biploar LoopGEI · Traditional 03/01/1996SE
K955346VFS - 300 Bipolar Electrosurgery SystemGEI · Traditional 12/08/1995SE

Questions and answers

When was Malis Surgical Loupes cleared by the FDA?

Malis Surgical Loupes (K874845) received a 510(k) decision of Substantially Equivalent on December 23, 1987, 29 days after the submission was received.

What is the product code of K874845?

The FDA product code is HJH – Loupe, Binocular, Low Power, a Class I (low risk) device regulated under 21 CFR 886.5120.