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FDA 510(k)

SPHEREX E.C.T.

K-Number: K822951 · 1982-10-26

ApplicantJeneric Ind.
Decision Date1982-10-26
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPHEREX E.C.T. is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric Ind.. It received FDA 510(k) clearance on 1982-10-26 under 510(k) number K822951. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPHEREX E.C.T.?

SPHEREX E.C.T. is a medical device that received FDA 510(k) clearance on 1982-10-26. The listed applicant is Jeneric Ind.. The 510(k) number is K822951.

When did SPHEREX E.C.T. receive FDA 510(k) clearance?

SPHEREX E.C.T. received FDA 510(k) clearance on 1982-10-26, under 510(k) number K822951.

Who is the listed applicant for SPHEREX E.C.T.?

The FDA 510(k) record lists Jeneric Ind. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPHEREX E.C.T.?

The FDA product code for SPHEREX E.C.T. is EJJ.

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Other records listing Jeneric Ind. 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.

K862822REXILLIUM N. B. F.K862926SURGICAL VITEXK854878H40 BASE METAL ALLOYK844123RX CBYK844122RX CBGK840561RX ELAN

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Related Devices (Code: EJJ)

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.

K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70SeptodontK033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.K032152BENCO ADMIXSouthern Dental Industries, Inc.K031658BENCO SPHERICALSouthern Dental Industries, Inc.K020452HIGH SILVER CONVENTIONALAb Ardent

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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