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FDA 510(k)

PLACIDO DISC

K-Number: K854054 · 1985-12-27

ApplicantCutler Medical Instruments
Decision Date1985-12-27
Product CodeHLR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PLACIDO DISC is the device name listed in this FDA 510(k) record. The listed applicant is Cutler Medical Instruments. It received FDA 510(k) clearance on 1985-12-27 under 510(k) number K854054. The device is classified under product code HLR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLACIDO DISC?

PLACIDO DISC is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is Cutler Medical Instruments. The 510(k) number is K854054.

When did PLACIDO DISC receive FDA 510(k) clearance?

PLACIDO DISC received FDA 510(k) clearance on 1985-12-27, under 510(k) number K854054.

Who is the listed applicant for PLACIDO DISC?

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

What is the FDA product code for PLACIDO DISC?

The FDA product code for PLACIDO DISC is HLR.

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Other records listing Cutler Medical Instruments 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.

K862343VACUUM HANDLE MODEL I/A - 1

Related Devices (Code: HLR)

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.

K901553SURG-K SURGICAL KERATOMETERThe Sanborn Co.K882902QRK 100, QUALITATIVE RING KERATOSCOPETechnitex, Inc.K882618JEDMED/POLACK KERATOSCOPE HS/SLGamut Ent.K864639REUSABLE SURGICAL KERATOSCOPEJedmed Instrument Co.K830008KARICKHOFF KERATOSCOPESurgidev Corp.K821080HAND KERATOSCOPEMedical Equipment Designs, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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