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FDA 510(k)

JEDMED/POLACK KERATOSCOPE HS/SL

K-Number: K882618 · 1988-07-13

ApplicantGamut Ent.
Decision Date1988-07-13
Product CodeHLR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

JEDMED/POLACK KERATOSCOPE HS/SL is the device name listed in this FDA 510(k) record. The listed applicant is Gamut Ent.. It received FDA 510(k) clearance on 1988-07-13 under 510(k) number K882618. 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 JEDMED/POLACK KERATOSCOPE HS/SL?

JEDMED/POLACK KERATOSCOPE HS/SL is a medical device that received FDA 510(k) clearance on 1988-07-13. The listed applicant is Gamut Ent.. The 510(k) number is K882618.

When did JEDMED/POLACK KERATOSCOPE HS/SL receive FDA 510(k) clearance?

JEDMED/POLACK KERATOSCOPE HS/SL received FDA 510(k) clearance on 1988-07-13, under 510(k) number K882618.

Who is the listed applicant for JEDMED/POLACK KERATOSCOPE HS/SL?

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

What is the FDA product code for JEDMED/POLACK KERATOSCOPE HS/SL?

The FDA product code for JEDMED/POLACK KERATOSCOPE HS/SL is HLR.

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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.K864639REUSABLE SURGICAL KERATOSCOPEJedmed Instrument Co.K854054PLACIDO DISCCutler Medical InstrumentsK830008KARICKHOFF 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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