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FDA 510(k)

SELF-CONTAINED MOBILE OPHTHAL. OPER. .

K-Number: K822427 · 1982-09-14

ApplicantSurgi-Quip Inc.U
Decision Date1982-09-14
Product CodeFSE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SELF-CONTAINED MOBILE OPHTHAL. OPER. . is the device name listed in this FDA 510(k) record. The listed applicant is Surgi-Quip Inc.U. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822427. The device is classified under product code FSE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF-CONTAINED MOBILE OPHTHAL. OPER. .?

SELF-CONTAINED MOBILE OPHTHAL. OPER. . is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Surgi-Quip Inc.U. The 510(k) number is K822427.

When did SELF-CONTAINED MOBILE OPHTHAL. OPER. . receive FDA 510(k) clearance?

SELF-CONTAINED MOBILE OPHTHAL. OPER. . received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822427.

Who is the listed applicant for SELF-CONTAINED MOBILE OPHTHAL. OPER. .?

The FDA 510(k) record lists Surgi-Quip Inc.U as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELF-CONTAINED MOBILE OPHTHAL. OPER. .?

The FDA product code for SELF-CONTAINED MOBILE OPHTHAL. OPER. . is FSE.

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Other records listing Surgi-Quip Inc.U 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.

K841116MOBILE OPHTHALMIC OPERATING TABLEK841115CHARLES/MCINTYRE GIANT BREAK TABLEK840004WEE BAG O'MERCURYK832887ELECTRONIC UNITK822554CEMENT EXTRACTION INSTRUMENTATIONK822428SURGI-QUIP MICROSCOPE STAND

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Related Devices (Code: FSE)

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.

K860503THE POREX RETRACTOR TABLEPorex MedicalK843801MASON EQUIPMENT ORGANIZER & ASPENAspen Laboratories, Inc.K840027OPERATING ROOM STANDHealthmate, Inc.K831042CHEMONUCLEOLYSIS TABLE EXTENSIONOrthopedic Systems, Inc.K830339IMSI/METRIPOND HAND OPERATING TABLEIntl. Management Services, Inc.K821924TABLE, OPERATING, FIELD 6530-00-709-8155Emerson-Sack-Warner Corp.

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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