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FDA 510(k)

SURGICAL INSTRUMENT KIT, DISPOSABLE

K-Number: K893814 · 1989-08-10

ApplicantBioseal
Decision Date1989-08-10
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL INSTRUMENT KIT, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Bioseal. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K893814. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL INSTRUMENT KIT, DISPOSABLE?

SURGICAL INSTRUMENT KIT, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Bioseal. The 510(k) number is K893814.

When did SURGICAL INSTRUMENT KIT, DISPOSABLE receive FDA 510(k) clearance?

SURGICAL INSTRUMENT KIT, DISPOSABLE received FDA 510(k) clearance on 1989-08-10, under 510(k) number K893814.

Who is the listed applicant for SURGICAL INSTRUMENT KIT, DISPOSABLE?

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

What is the FDA product code for SURGICAL INSTRUMENT KIT, DISPOSABLE?

The FDA product code for SURGICAL INSTRUMENT KIT, DISPOSABLE is LRO.

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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

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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