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FDA 510(k)

GENERAL PURPOSE KIT

K-Number: K881083 · 1988-04-07

ApplicantMed-Dex Intl.
Decision Date1988-04-07
Product CodeLRO
Advisory CommitteeSU
DecisionUnknown

Device Summary

GENERAL PURPOSE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Med-Dex Intl.. It received FDA 510(k) clearance on 1988-04-07 under 510(k) number K881083. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GENERAL PURPOSE KIT?

GENERAL PURPOSE KIT is a medical device that received FDA 510(k) clearance on 1988-04-07. The listed applicant is Med-Dex Intl.. The 510(k) number is K881083.

When did GENERAL PURPOSE KIT receive FDA 510(k) clearance?

GENERAL PURPOSE KIT received FDA 510(k) clearance on 1988-04-07, under 510(k) number K881083.

Who is the listed applicant for GENERAL PURPOSE KIT?

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

What is the FDA product code for GENERAL PURPOSE KIT?

The FDA product code for GENERAL PURPOSE KIT is LRO.

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.

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Other records listing Med-Dex Intl. 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.

K893569QUICK CHANGE MONTGOMERY STRAPK884630MULTI-PURPOSE HOLDERK881084UTILITY CLAMP

Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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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