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FDA 510(k)

PELICAN BAY KEL-COR CEPHALOMETRIC SYS.

K-Number: K791916 · 1979-11-05

ApplicantPelican Bay Kel-Cor
Decision Date1979-11-05
Product CodeIXY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PELICAN BAY KEL-COR CEPHALOMETRIC SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Pelican Bay Kel-Cor. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K791916. The device is classified under product code IXY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELICAN BAY KEL-COR CEPHALOMETRIC SYS.?

PELICAN BAY KEL-COR CEPHALOMETRIC SYS. is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Pelican Bay Kel-Cor. The 510(k) number is K791916.

When did PELICAN BAY KEL-COR CEPHALOMETRIC SYS. receive FDA 510(k) clearance?

PELICAN BAY KEL-COR CEPHALOMETRIC SYS. received FDA 510(k) clearance on 1979-11-05, under 510(k) number K791916.

Who is the listed applicant for PELICAN BAY KEL-COR CEPHALOMETRIC SYS.?

The FDA 510(k) record lists Pelican Bay Kel-Cor as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PELICAN BAY KEL-COR CEPHALOMETRIC SYS.?

The FDA product code for PELICAN BAY KEL-COR CEPHALOMETRIC SYS. is IXY.

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Related Devices (Code: IXY)

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.

K953336VRS 3 WALL STANDPhilips Medical Systems (Cleveland), Inc.K953402UNIVERSIX 190Philips Medical Systems (Cleveland), Inc.K946114SENSORI-MOTOR RATING SCALECmedK946260NTBS-1417, 1436, TBS-1417Scott Imaging Intl., Inc.K930249BC/WT/PFTingle X-Ray Products, Inc.K930230RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDERAmerican Medical Sales, Inc.

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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