FDA 510(k)

MICRO VIT FRAGMENTATION SYSTEM

K-Number: K834537 · 1984-03-16

ApplicantMedical Instrument Development Laboratories, Inc.

Decision Date1984-03-16

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MICRO VIT FRAGMENTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Development Laboratories, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834537. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO VIT FRAGMENTATION SYSTEM?

MICRO VIT FRAGMENTATION SYSTEM is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Medical Instrument Development Laboratories, Inc.. The 510(k) number is K834537.

When did MICRO VIT FRAGMENTATION SYSTEM receive FDA 510(k) clearance?

MICRO VIT FRAGMENTATION SYSTEM received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834537.

Who is the listed applicant for MICRO VIT FRAGMENTATION SYSTEM?

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

What is the FDA product code for MICRO VIT FRAGMENTATION SYSTEM?

The FDA product code for MICRO VIT FRAGMENTATION SYSTEM is HQC.

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Other records listing Medical Instrument Development Laboratories, Inc. as applicant

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Related Devices (Code: HQC)

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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.