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FDA 510(k)

STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY

K-Number: K905460 · 1991-02-06

ApplicantAngiosystems, Inc.
Decision Date1991-02-06
Product CodeHMT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Angiosystems, Inc.. It received FDA 510(k) clearance on 1991-02-06 under 510(k) number K905460. 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 STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY?

STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY is a medical device that received FDA 510(k) clearance on 1991-02-06. The listed applicant is Angiosystems, Inc.. The 510(k) number is K905460.

When did STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY receive FDA 510(k) clearance?

STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY received FDA 510(k) clearance on 1991-02-06, under 510(k) number K905460.

Who is the listed applicant for STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY?

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

What is the FDA product code for STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY?

The FDA product code for STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY 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 Angiosystems, Inc. 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.

K905464MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLINGK905459SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOMK905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESK905466STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPEK905465STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPEK905462PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES

View all 14 devices →

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.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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