Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMSEAL SURGICAL FACE MASK

K-Number: K964358 · 1997-02-14

ApplicantAmerican Seal Co.
Decision Date1997-02-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMSEAL SURGICAL FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is American Seal Co.. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K964358. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSEAL SURGICAL FACE MASK?

AMSEAL SURGICAL FACE MASK is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is American Seal Co.. The 510(k) number is K964358.

When did AMSEAL SURGICAL FACE MASK receive FDA 510(k) clearance?

AMSEAL SURGICAL FACE MASK received FDA 510(k) clearance on 1997-02-14, under 510(k) number K964358.

Who is the listed applicant for AMSEAL SURGICAL FACE MASK?

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

What is the FDA product code for AMSEAL SURGICAL FACE MASK?

The FDA product code for AMSEAL SURGICAL FACE MASK is FXX.

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 American Seal Co. 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.

K972187BOUFFANT CAPK972227SHOE COVERK970814NON-STERILE ISOLATION GOWNK892557MAYTEX NON-STERILE LATEX EXAM GLOVEK892553MAYTEX PATIENT EXAMINATION GLOVES

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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.

↑