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FDA 510(k)

KARICKHOFF KERATOSCOPE

K-Number: K830008 · 1983-01-26

ApplicantSurgidev Corp.
Decision Date1983-01-26
Product CodeHLR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KARICKHOFF KERATOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgidev Corp.. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K830008. 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 KARICKHOFF KERATOSCOPE?

KARICKHOFF KERATOSCOPE is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Surgidev Corp.. The 510(k) number is K830008.

When did KARICKHOFF KERATOSCOPE receive FDA 510(k) clearance?

KARICKHOFF KERATOSCOPE received FDA 510(k) clearance on 1983-01-26, under 510(k) number K830008.

Who is the listed applicant for KARICKHOFF KERATOSCOPE?

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

What is the FDA product code for KARICKHOFF KERATOSCOPE?

The FDA product code for KARICKHOFF KERATOSCOPE is HLR.

Related Clinical Trials

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.

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Other records listing Surgidev Corp. 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.

K850729ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000K831829KARICKHOFF FLYING CORPUSCLE VIEWERK831975LEADING EDGE OPHTHALMIC KNIFE

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.K854054PLACIDO DISCCutler Medical InstrumentsK821080HAND KERATOSCOPEMedical Equipment Designs, 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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