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FDA 510(k)

DONALDSON NATURAL EYEPATCH 'PATIENT PAK'

K-Number: K874411 · 1988-01-27

ApplicantKeeler Instruments, Inc.
Decision Date1988-01-27
Product CodeHMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DONALDSON NATURAL EYEPATCH 'PATIENT PAK' is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1988-01-27 under 510(k) number K874411. 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 DONALDSON NATURAL EYEPATCH 'PATIENT PAK'?

DONALDSON NATURAL EYEPATCH 'PATIENT PAK' is a medical device that received FDA 510(k) clearance on 1988-01-27. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K874411.

When did DONALDSON NATURAL EYEPATCH 'PATIENT PAK' receive FDA 510(k) clearance?

DONALDSON NATURAL EYEPATCH 'PATIENT PAK' received FDA 510(k) clearance on 1988-01-27, under 510(k) number K874411.

Who is the listed applicant for DONALDSON NATURAL EYEPATCH 'PATIENT PAK'?

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

What is the FDA product code for DONALDSON NATURAL EYEPATCH 'PATIENT PAK'?

The FDA product code for DONALDSON NATURAL EYEPATCH 'PATIENT PAK' is HMP.

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Other records listing Keeler Instruments, 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.

K181143Keeler TonoCare TonometerK112093CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTERK093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000K100500PSL CLASSIC SLIT LAMPK062412CRYOMATICK060822VANTAGE INDIRECT OPHTHALMOSCOPE

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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.K864810LIDSPLINTPrecision Therapeutics, Inc.K861456SHEETS LYOPHILIZED COLLAGEN HEYEDRATORPantheon 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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