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FDA 510(k)

ESPI APPLICATOR SLEEVE, #8410

K-Number: K903593 · 1990-09-12

ApplicantDixon Medical, Inc.
Decision Date1990-09-12
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ESPI APPLICATOR SLEEVE, #8410 is the device name listed in this FDA 510(k) record. The listed applicant is Dixon Medical, Inc.. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K903593. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPI APPLICATOR SLEEVE, #8410?

ESPI APPLICATOR SLEEVE, #8410 is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Dixon Medical, Inc.. The 510(k) number is K903593.

When did ESPI APPLICATOR SLEEVE, #8410 receive FDA 510(k) clearance?

ESPI APPLICATOR SLEEVE, #8410 received FDA 510(k) clearance on 1990-09-12, under 510(k) number K903593.

Who is the listed applicant for ESPI APPLICATOR SLEEVE, #8410?

The FDA 510(k) record lists Dixon Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESPI APPLICATOR SLEEVE, #8410?

The FDA product code for ESPI APPLICATOR SLEEVE, #8410 is HET.

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Other records listing Dixon Medical, Inc. 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.

K903598ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-NK903600ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-NK903599ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-NK903591ESPI HOOK/UNIVERSAL SCISSORS, # 8101K903595ESPI CLAW FORCEP, #8302, 10MM, 30CMK903601ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204

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Related Devices (Code: HET)

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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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