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FDA 510(k)

SURGICAL EYE PACK

K-Number: K851906 · 1985-05-21

ApplicantXanmed Corp.
Decision Date1985-05-21
Product CodeHMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL EYE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Xanmed Corp.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K851906. The device is classified under product code HMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL EYE PACK?

SURGICAL EYE PACK is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Xanmed Corp.. The 510(k) number is K851906.

When did SURGICAL EYE PACK receive FDA 510(k) clearance?

SURGICAL EYE PACK received FDA 510(k) clearance on 1985-05-21, under 510(k) number K851906.

Who is the listed applicant for SURGICAL EYE PACK?

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

What is the FDA product code for SURGICAL EYE PACK?

The FDA product code for SURGICAL EYE PACK is HMP.

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Other records listing Xanmed Corp. 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.

K864623OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KITK844595ORTHOPEDIC CUSTOM SURGICAL KITK844596EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KITK844593CARDIOVASCULAR CUSTOM SURGICAL KITK844594NEURO CUSTOM SURGICAL KITK844597MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT

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Related Devices (Code: HMP)

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.

K940333EYE PADCertified Safety Mfg., Inc.K921349STERILE,DISPOSABLE EYE DRESSINGDeroyal Industries, Inc.K904896EYE PADUlti-Med Intl., Inc.K883822FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309Consolidated Industries of Greater Syracuse, Inc.K874411DONALDSON NATURAL EYEPATCH 'PATIENT PAK'Keeler Instruments, Inc.K864810LIDSPLINTPrecision Therapeutics, 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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