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FDA 510(k)

ENVISION G21 I/A ENPAK

K-Number: K832423 · 1983-09-12

ApplicantEnvision, Inc.
Decision Date1983-09-12
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENVISION G21 I/A ENPAK is the device name listed in this FDA 510(k) record. The listed applicant is Envision, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832423. 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 ENVISION G21 I/A ENPAK?

ENVISION G21 I/A ENPAK is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Envision, Inc.. The 510(k) number is K832423.

When did ENVISION G21 I/A ENPAK receive FDA 510(k) clearance?

ENVISION G21 I/A ENPAK received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832423.

Who is the listed applicant for ENVISION G21 I/A ENPAK?

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

What is the FDA product code for ENVISION G21 I/A ENPAK?

The FDA product code for ENVISION G21 I/A ENPAK is HQC.

Related Clinical Trials

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Other records listing Envision, 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.

K832424ENVISION G31 P.E. PAK

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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