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FDA 510(k)

VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE

K-Number: K945738 · 1995-02-14

ApplicantVisitec Co.
Decision Date1995-02-14
Product CodeHMT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1995-02-14 under 510(k) number K945738. 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 VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE?

VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Visitec Co.. The 510(k) number is K945738.

When did VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE receive FDA 510(k) clearance?

VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE received FDA 510(k) clearance on 1995-02-14, under 510(k) number K945738.

Who is the listed applicant for VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE?

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

What is the FDA product code for VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE?

The FDA product code for VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE is HMT.

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Other records listing Visitec 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTSK940210VISITEC EYE PAD

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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.

K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYAngiosystems, Inc.K872620SOLOS EYESITE DRAPESSolos OphthalmologyK871706OPTHA PREPTreace Medical, Inc.K854613SURGICAL DRAPES, OPHTHALMINCharles Atkins & Co.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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