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FDA 510(k)

SURGICAL DRAPES, OPHTHALMIN

K-Number: K854613 · 1986-02-13

ApplicantCharles Atkins & Co.
Decision Date1986-02-13
Product CodeHMT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRAPES, OPHTHALMIN is the device name listed in this FDA 510(k) record. The listed applicant is Charles Atkins & Co.. It received FDA 510(k) clearance on 1986-02-13 under 510(k) number K854613. The device is classified under product code HMT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL DRAPES, OPHTHALMIN?

SURGICAL DRAPES, OPHTHALMIN is a medical device that received FDA 510(k) clearance on 1986-02-13. The listed applicant is Charles Atkins & Co.. The 510(k) number is K854613.

When did SURGICAL DRAPES, OPHTHALMIN receive FDA 510(k) clearance?

SURGICAL DRAPES, OPHTHALMIN received FDA 510(k) clearance on 1986-02-13, under 510(k) number K854613.

Who is the listed applicant for SURGICAL DRAPES, OPHTHALMIN?

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

What is the FDA product code for SURGICAL DRAPES, OPHTHALMIN?

The FDA product code for SURGICAL DRAPES, OPHTHALMIN is HMT.

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 Charles Atkins & 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.

K853759CUSTOM PROCEDURAL TRAY PROCEDURAL KIT

Related Devices (Code: HMT)

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.

K945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEVisitec Co.K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYAngiosystems, Inc.K872620SOLOS EYESITE DRAPESSolos OphthalmologyK871706OPTHA PREPTreace Medical, Inc.K831340DRAIN-R-DRAPE(EYESur-Tech, Inc.K830822EYE DRAPECooperVision, 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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