FDA 510(k)

VITRECTOMY PACK #J120

K-Number: K891161 · 1989-05-26

Decision Date1989-05-26

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

VITRECTOMY PACK #J120 is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Specialties, Inc.. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K891161. 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 VITRECTOMY PACK #J120?

VITRECTOMY PACK #J120 is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is O.R. Specialties, Inc.. The 510(k) number is K891161.

When did VITRECTOMY PACK #J120 receive FDA 510(k) clearance?

VITRECTOMY PACK #J120 received FDA 510(k) clearance on 1989-05-26, under 510(k) number K891161.

Who is the listed applicant for VITRECTOMY PACK #J120?

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

What is the FDA product code for VITRECTOMY PACK #J120?

The FDA product code for VITRECTOMY PACK #J120 is HQC.

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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.