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FDA 510(k)

HEALTH-PAK/WYCOMBE CSR WRAP

K-Number: K872754 · 1987-08-06

ApplicantHealth-Pak, Inc.
Decision Date1987-08-06
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEALTH-PAK/WYCOMBE CSR WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Health-Pak, Inc.. It received FDA 510(k) clearance on 1987-08-06 under 510(k) number K872754. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTH-PAK/WYCOMBE CSR WRAP?

HEALTH-PAK/WYCOMBE CSR WRAP is a medical device that received FDA 510(k) clearance on 1987-08-06. The listed applicant is Health-Pak, Inc.. The 510(k) number is K872754.

When did HEALTH-PAK/WYCOMBE CSR WRAP receive FDA 510(k) clearance?

HEALTH-PAK/WYCOMBE CSR WRAP received FDA 510(k) clearance on 1987-08-06, under 510(k) number K872754.

Who is the listed applicant for HEALTH-PAK/WYCOMBE CSR WRAP?

The FDA 510(k) record lists Health-Pak, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALTH-PAK/WYCOMBE CSR WRAP?

The FDA product code for HEALTH-PAK/WYCOMBE CSR WRAP is FRG.

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

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

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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