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FDA 510(k)

CUSTOM ENT PACKS

K-Number: K935621 · 1994-03-30

ApplicantAssociated Medical
Decision Date1994-03-30
Product CodeLRP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUSTOM ENT PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Associated Medical. It received FDA 510(k) clearance on 1994-03-30 under 510(k) number K935621. 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 CUSTOM ENT PACKS?

CUSTOM ENT PACKS is a medical device that received FDA 510(k) clearance on 1994-03-30. The listed applicant is Associated Medical. The 510(k) number is K935621.

When did CUSTOM ENT PACKS receive FDA 510(k) clearance?

CUSTOM ENT PACKS received FDA 510(k) clearance on 1994-03-30, under 510(k) number K935621.

Who is the listed applicant for CUSTOM ENT PACKS?

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

What is the FDA product code for CUSTOM ENT PACKS?

The FDA product code for CUSTOM ENT PACKS 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 Associated Medical 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.

K936255CUSTOM CV PACKK935622CUSTOM PLASTIC PACKS

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 ProductsK940646ORTHOPEDIC TRAY PRODUCT LINECushinduK940444GENERAL SURGERY TRAYCush Medical ProductsK922126HOSPITAL KIT ENT 1125Savoy Medical Supply Co., Inc.

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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