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FDA 510(k)

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)

K-Number: K860358 · 1986-03-21

ApplicantHgm, Inc.
Decision Date1986-03-21
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Hgm, Inc.. It received FDA 510(k) clearance on 1986-03-21 under 510(k) number K860358. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)?

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) is a medical device that received FDA 510(k) clearance on 1986-03-21. The listed applicant is Hgm, Inc.. The 510(k) number is K860358.

When did FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) receive FDA 510(k) clearance?

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) received FDA 510(k) clearance on 1986-03-21, under 510(k) number K860358.

Who is the listed applicant for FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)?

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

What is the FDA product code for FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)?

The FDA product code for FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) is HQF.

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Other records listing Hgm, 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.

K950120SMART PLUGK931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEK931784HGM ILLUMINATING IMAGING ENDOCULAR PROBEK933333HGM SCANMAN PLUSK931499Q-11 OPHTHALMIC LASERK925663HGM ASPIRATING ENDOOCULAR(TM) PROBE

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Related Devices (Code: HQF)

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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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