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FDA 510(k)

JAMES TENDOS (SYRINGE HOLDER)

K-Number: K875297 · 1988-04-19

Decision Date1988-04-19
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JAMES TENDOS (SYRINGE HOLDER) is the device name listed in this FDA 510(k) record. The listed applicant is Med-Text Intl.. It received FDA 510(k) clearance on 1988-04-19 under 510(k) number K875297. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAMES TENDOS (SYRINGE HOLDER)?

JAMES TENDOS (SYRINGE HOLDER) is a medical device that received FDA 510(k) clearance on 1988-04-19. The listed applicant is Med-Text Intl.. The 510(k) number is K875297.

When did JAMES TENDOS (SYRINGE HOLDER) receive FDA 510(k) clearance?

JAMES TENDOS (SYRINGE HOLDER) received FDA 510(k) clearance on 1988-04-19, under 510(k) number K875297.

Who is the listed applicant for JAMES TENDOS (SYRINGE HOLDER)?

The FDA 510(k) record lists Med-Text Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAMES TENDOS (SYRINGE HOLDER)?

The FDA product code for JAMES TENDOS (SYRINGE HOLDER) is FMF.

Related Clinical Trials

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.

Related Devices (Code: FMF)

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.

Official Source

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

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