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FDA 510(k)

GFB-B CONTACT LENS BLANKS

K-Number: K822315 · 1982-11-16

ApplicantHamel, Park, Mccabe & Saunders
Decision Date1982-11-16
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

GFB-B CONTACT LENS BLANKS is the device name listed in this FDA 510(k) record. The listed applicant is Hamel, Park, Mccabe & Saunders. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K822315. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GFB-B CONTACT LENS BLANKS?

GFB-B CONTACT LENS BLANKS is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Hamel, Park, Mccabe & Saunders. The 510(k) number is K822315.

When did GFB-B CONTACT LENS BLANKS receive FDA 510(k) clearance?

GFB-B CONTACT LENS BLANKS received FDA 510(k) clearance on 1982-11-16, under 510(k) number K822315.

Who is the listed applicant for GFB-B CONTACT LENS BLANKS?

The FDA 510(k) record lists Hamel, Park, Mccabe & Saunders as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GFB-B CONTACT LENS BLANKS?

The FDA product code for GFB-B CONTACT LENS BLANKS is HPX.

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.

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Other records listing Hamel, Park, Mccabe & Saunders 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.

K822058GELIPERM TRANSPARENT GEL-FILM DRESSINGK822073GELIPERM DRY

Related Devices (Code: HPX)

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.

K955777PMMA CLASICRand Scientific Corp.K940106KERATOPLASTY SUTURING LENSVisionary Technologies of Miami, Inc.K913081MULTI-VIEW BIFOCALSCamp Contact LensesK897021MARTIN-HENSLEY SEGMENT LENSBruce W. Martin O.D. and Edward HensleyK895411OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.K874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, Co.

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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