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FDA 510(k)

STERISEAL OPHTHALMIC CANNULA

K-Number: K943932 · 1995-01-18

ApplicantPharma-Plast, Ltd.
Decision Date1995-01-18
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STERISEAL OPHTHALMIC CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Plast, Ltd.. It received FDA 510(k) clearance on 1995-01-18 under 510(k) number K943932. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERISEAL OPHTHALMIC CANNULA?

STERISEAL OPHTHALMIC CANNULA is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is Pharma-Plast, Ltd.. The 510(k) number is K943932.

When did STERISEAL OPHTHALMIC CANNULA receive FDA 510(k) clearance?

STERISEAL OPHTHALMIC CANNULA received FDA 510(k) clearance on 1995-01-18, under 510(k) number K943932.

Who is the listed applicant for STERISEAL OPHTHALMIC CANNULA?

The FDA 510(k) record lists Pharma-Plast, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERISEAL OPHTHALMIC CANNULA?

The FDA product code for STERISEAL OPHTHALMIC CANNULA is HMX.

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Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, Inc.K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECEKirwan Surgical Products, Inc.

Official Source

View on FDA Database →

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

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