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FDA 510(k)

PRO-PAK FOR OMS DIPLOMATE

K-Number: K950800 · 1995-05-22

ApplicantM. Imonti and Associates Inc.,
Decision Date1995-05-22
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PRO-PAK FOR OMS DIPLOMATE is the device name listed in this FDA 510(k) record. The listed applicant is M. Imonti and Associates Inc.,. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K950800. 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 PRO-PAK FOR OMS DIPLOMATE?

PRO-PAK FOR OMS DIPLOMATE is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is M. Imonti and Associates Inc.,. The 510(k) number is K950800.

When did PRO-PAK FOR OMS DIPLOMATE receive FDA 510(k) clearance?

PRO-PAK FOR OMS DIPLOMATE received FDA 510(k) clearance on 1995-05-22, under 510(k) number K950800.

Who is the listed applicant for PRO-PAK FOR OMS DIPLOMATE?

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

What is the FDA product code for PRO-PAK FOR OMS DIPLOMATE?

The FDA product code for PRO-PAK FOR OMS DIPLOMATE is HQC.

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Other records listing M. Imonti and Associates 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.

K950799PRO-VITK933627PHACOFRAGMENTOR TIPK933503PRO-PHACO HANDPIECEK924551ENDO TRACHEA TUBE FIXATIONK905766DRAINAGE TUBE RESTRAINT/WOUND COVER

Related Devices (Code: HQC)

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.

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 LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 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.

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