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FDA 510(k)

MENTOR(R) SUR-E-TROL(R)

K-Number: K910637 · 1991-05-13

ApplicantMentor O & O, Inc.
Decision Date1991-05-13
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MENTOR(R) SUR-E-TROL(R) is the device name listed in this FDA 510(k) record. The listed applicant is Mentor O & O, Inc.. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K910637. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR(R) SUR-E-TROL(R)?

MENTOR(R) SUR-E-TROL(R) is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Mentor O & O, Inc.. The 510(k) number is K910637.

When did MENTOR(R) SUR-E-TROL(R) receive FDA 510(k) clearance?

MENTOR(R) SUR-E-TROL(R) received FDA 510(k) clearance on 1991-05-13, under 510(k) number K910637.

Who is the listed applicant for MENTOR(R) SUR-E-TROL(R)?

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

What is the FDA product code for MENTOR(R) SUR-E-TROL(R)?

The FDA product code for MENTOR(R) SUR-E-TROL(R) is FRN.

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Other records listing Mentor O & O, Inc. as applicant

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K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEMK934320MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATIONK912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEMK915340MENTOR HORIZON LOW VISION MAGNIFIERK911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305K903878MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT

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Related Devices (Code: FRN)

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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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