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FDA 510(k)

STERILE DISPOSABLE SURGICAL PACKS

K-Number: K884093 · 1988-10-19

ApplicantBolden Surgical Products
Decision Date1988-10-19
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE SURGICAL PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Bolden Surgical Products. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K884093. 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 STERILE DISPOSABLE SURGICAL PACKS?

STERILE DISPOSABLE SURGICAL PACKS is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Bolden Surgical Products. The 510(k) number is K884093.

When did STERILE DISPOSABLE SURGICAL PACKS receive FDA 510(k) clearance?

STERILE DISPOSABLE SURGICAL PACKS received FDA 510(k) clearance on 1988-10-19, under 510(k) number K884093.

Who is the listed applicant for STERILE DISPOSABLE SURGICAL PACKS?

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

What is the FDA product code for STERILE DISPOSABLE SURGICAL PACKS?

The FDA product code for STERILE DISPOSABLE SURGICAL PACKS 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

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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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