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FDA 510(k)

STERILE PACK (PROCEDURAL TRAY/KITS)

K-Number: K882275 · 1988-07-18

ApplicantEast Texas Lighthouse For the Blind
Decision Date1988-07-18
Product CodeLRP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE PACK (PROCEDURAL TRAY/KITS) is the device name listed in this FDA 510(k) record. The listed applicant is East Texas Lighthouse For the Blind. It received FDA 510(k) clearance on 1988-07-18 under 510(k) number K882275. The device is classified under product code LRP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE PACK (PROCEDURAL TRAY/KITS)?

STERILE PACK (PROCEDURAL TRAY/KITS) is a medical device that received FDA 510(k) clearance on 1988-07-18. The listed applicant is East Texas Lighthouse For the Blind. The 510(k) number is K882275.

When did STERILE PACK (PROCEDURAL TRAY/KITS) receive FDA 510(k) clearance?

STERILE PACK (PROCEDURAL TRAY/KITS) received FDA 510(k) clearance on 1988-07-18, under 510(k) number K882275.

Who is the listed applicant for STERILE PACK (PROCEDURAL TRAY/KITS)?

The FDA 510(k) record lists East Texas Lighthouse For the Blind as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE PACK (PROCEDURAL TRAY/KITS)?

The FDA product code for STERILE PACK (PROCEDURAL TRAY/KITS) is LRP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing East Texas Lighthouse For the Blind 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.

K883376STERILIZATION WRAP TYPE 22,44,77K863733TOWEL PACK, SURGICALK862062NONWOVEN SURGICAL DRAPE PACKK850067MEDICAL, DISPOSABLE BEDDINGK850811PAD, PRE-OPERATIVE PREPARATIONK850016TOWEL PACK, SURGICAL

View all 7 devices →

Related Devices (Code: LRP)

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.

K963723LACERATION TRAYGrand Medical ProductsK951811OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACKOsteotech, Inc.K940239EYE TRAYCush Medical ProductsK935621CUSTOM ENT PACKSAssociated MedicalK940646ORTHOPEDIC TRAY PRODUCT LINECushinduK940444GENERAL SURGERY TRAYCush Medical Products

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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