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FDA 510(k)

DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.

K-Number: K883975 · 1988-10-25

ApplicantSite Microsurgical Systems, Inc.
Decision Date1988-10-25
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. is the device name listed in this FDA 510(k) record. The listed applicant is Site Microsurgical Systems, Inc.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883975. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.?

DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K883975.

When did DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. receive FDA 510(k) clearance?

DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883975.

Who is the listed applicant for DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.?

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

What is the FDA product code for DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.?

The FDA product code for DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. is HQE.

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Other records listing Site Microsurgical Systems, 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.

K925828MODIFIED SITE TXR SYSTEMSK925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTEK931866SITE'S CD II PHACOEMULSIFICATION HANDPIECEK921135IOLAB POWER I.V. POLEK920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

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Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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