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FDA 510(k)

REFRACTEC MCS-100

K-Number: K980522 · 1998-07-22

ApplicantRefractec, Inc.
Decision Date1998-07-22
Product CodeHQR
Advisory CommitteeOP
DecisionUnknown

Device Summary

REFRACTEC MCS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Refractec, Inc.. It received FDA 510(k) clearance on 1998-07-22 under 510(k) number K980522. The device is classified under product code HQR. It was reviewed by the OP advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the REFRACTEC MCS-100?

REFRACTEC MCS-100 is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Refractec, Inc.. The 510(k) number is K980522.

When did REFRACTEC MCS-100 receive FDA 510(k) clearance?

REFRACTEC MCS-100 received FDA 510(k) clearance on 1998-07-22, under 510(k) number K980522.

Who is the listed applicant for REFRACTEC MCS-100?

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

What is the FDA product code for REFRACTEC MCS-100?

The FDA product code for REFRACTEC MCS-100 is HQR.

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Other records listing Refractec, 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.

K053475OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450

Related Devices (Code: HQR)

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.

K050308THERMAL CAUTERY PROBEStarion InstrumentsK990064DI-RHEX OPHTHALMIC DIATHERMY SYSTEMOphthalmic Technologies, Inc.K972749PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)C.M. Chance , Ltd.K952151STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)StorzK955158SURGITRONEllman Intl., Inc.K952569GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATORGamp & Assoc.

Official Source

View on FDA Database →

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