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FDA 510(k)

SEBESTYEN IRRIGATING CONTACT LENS

K-Number: K802927 · 1981-02-05

ApplicantCooper Medical Devices Corp.
Decision Date1981-02-05
Product CodeHJI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SEBESTYEN IRRIGATING CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Medical Devices Corp.. It received FDA 510(k) clearance on 1981-02-05 under 510(k) number K802927. The device is classified under product code HJI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEBESTYEN IRRIGATING CONTACT LENS?

SEBESTYEN IRRIGATING CONTACT LENS is a medical device that received FDA 510(k) clearance on 1981-02-05. The listed applicant is Cooper Medical Devices Corp.. The 510(k) number is K802927.

When did SEBESTYEN IRRIGATING CONTACT LENS receive FDA 510(k) clearance?

SEBESTYEN IRRIGATING CONTACT LENS received FDA 510(k) clearance on 1981-02-05, under 510(k) number K802927.

Who is the listed applicant for SEBESTYEN IRRIGATING CONTACT LENS?

The FDA 510(k) record lists Cooper Medical Devices Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEBESTYEN IRRIGATING CONTACT LENS?

The FDA product code for SEBESTYEN IRRIGATING CONTACT LENS is HJI.

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Other records listing Cooper Medical Devices Corp. 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.

K802971LANDERS CONTACT LENSK801850CHARLES PNEUMATIC INTRAOCULAR SCISSORSK801411MAY ILLUMINATED/INFUSION PICK801312THE PROTECTORSK800833VABRA ASPIRATORK791898OCUTOME MODEL 8000

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Related Devices (Code: HJI)

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.

K923670BYRNE EXPULSIVE LENSOcular Instruments, Inc.K902138STRIPE PROJECTORAcademic Catalyst Corp.K90183960 FUNDUS CAMERA CF-60UVCanon USA, Inc.K897186LASER IMAGING WORK STATIONInnovision Medical, Inc.K820223OMS QUARTZ INFUSION CONTACT LENSOptical Micro Systems, Inc.K802971LANDERS CONTACT LENSCooper Medical Devices Corp.

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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