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FDA 510(k)

PAPILLION PROCTOSCOPE

K-Number: K914784 · 1992-06-05

ApplicantOldelft Corp. of America
Decision Date1992-06-05
Product CodeKQA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PAPILLION PROCTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Oldelft Corp. of America. It received FDA 510(k) clearance on 1992-06-05 under 510(k) number K914784. The device is classified under product code KQA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAPILLION PROCTOSCOPE?

PAPILLION PROCTOSCOPE is a medical device that received FDA 510(k) clearance on 1992-06-05. The listed applicant is Oldelft Corp. of America. The 510(k) number is K914784.

When did PAPILLION PROCTOSCOPE receive FDA 510(k) clearance?

PAPILLION PROCTOSCOPE received FDA 510(k) clearance on 1992-06-05, under 510(k) number K914784.

Who is the listed applicant for PAPILLION PROCTOSCOPE?

The FDA 510(k) record lists Oldelft Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAPILLION PROCTOSCOPE?

The FDA product code for PAPILLION PROCTOSCOPE is KQA.

Related Clinical Trials

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Other records listing Oldelft Corp. of America as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980296OLDELFT DIGIDELCAK973219AMBER DUK946128SIMULIX-HPK950037N 800 HFK932848SIMULIX-MC CT EXTENSIONK923584THERAPAX DXT 300 SERIES 3

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Related Devices (Code: KQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K885126PHILIPS RT250 COLLIMATOR (PK8050)Perkins Mfg. Co.K844180THE MCP-70-SE SYSTEMEllis Pharmaceutical Consulting, Inc.K790168COLLIMATOR, BILATERIALCmsi

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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