Papillion Proctoscope

FDA 510(k) K914784 · Oldelft Corp. of America

Substantially Equivalent

510(k) numberK914784

Submission

Device name
Papillion Proctoscope
Applicant
Oldelft Corp. of America
Fairfax, VA, US
Received
October 23, 1991
Decision date
June 5, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KQA – Device, Beam Limiting, X-Ray, Therapeutic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5900
Specialty
Radiology

Other 510(k)s with product code KQA

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K844180The MCP-70-SE SystemKQA · Traditional Ellis Pharmaceutical Consulting, Inc.02/01/1985SE
K790168Collimator, BilaterialKQA · Traditional Cmsi02/15/1979SE

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Questions and answers

When was Papillion Proctoscope cleared by the FDA?

Papillion Proctoscope (K914784) received a 510(k) decision of Substantially Equivalent on June 5, 1992, 226 days after the submission was received.

What is the product code of K914784?

The FDA product code is KQA – Device, Beam Limiting, X-Ray, Therapeutic, a Class II (moderate risk) device regulated under 21 CFR 892.5900.