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FDA 510(k)

EAR-A-GATOR

K-Number: K946108 · 1995-06-13

ApplicantLife-Tech Intl., Inc.
Decision Date1995-06-13
Product CodeKHH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EAR-A-GATOR is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1995-06-13 under 510(k) number K946108. The device is classified under product code KHH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR-A-GATOR?

EAR-A-GATOR is a medical device that received FDA 510(k) clearance on 1995-06-13. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K946108.

When did EAR-A-GATOR receive FDA 510(k) clearance?

EAR-A-GATOR received FDA 510(k) clearance on 1995-06-13, under 510(k) number K946108.

Who is the listed applicant for EAR-A-GATOR?

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

What is the FDA product code for EAR-A-GATOR?

The FDA product code for EAR-A-GATOR is KHH.

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Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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Related Devices (Code: KHH)

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.

K950785HORTMANN AIRMATIC AIR CALORIC STIMULATORJedmed Instrument Co.K941325WATER IRRIGATOR, W1 200Strong Medical, Inc.K931608NCA-200Ics Medical Corp.K925237AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.K881630AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.K822179FRENZEL EYEGLASSES & RELATED ITEMSKelleher Corp.

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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