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FDA 510(k)

SITE STERILIZATION TRAYS FOR OPHTHALMIC USE

K-Number: K883098 · 1988-08-18

ApplicantSite Microsurgical Systems, Inc.
Decision Date1988-08-18
Product CodeLRP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SITE STERILIZATION TRAYS FOR OPHTHALMIC USE is the device name listed in this FDA 510(k) record. The listed applicant is Site Microsurgical Systems, Inc.. It received FDA 510(k) clearance on 1988-08-18 under 510(k) number K883098. The device is classified under product code LRP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SITE STERILIZATION TRAYS FOR OPHTHALMIC USE?

SITE STERILIZATION TRAYS FOR OPHTHALMIC USE is a medical device that received FDA 510(k) clearance on 1988-08-18. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K883098.

When did SITE STERILIZATION TRAYS FOR OPHTHALMIC USE receive FDA 510(k) clearance?

SITE STERILIZATION TRAYS FOR OPHTHALMIC USE received FDA 510(k) clearance on 1988-08-18, under 510(k) number K883098.

Who is the listed applicant for SITE STERILIZATION TRAYS FOR OPHTHALMIC USE?

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

What is the FDA product code for SITE STERILIZATION TRAYS FOR OPHTHALMIC USE?

The FDA product code for SITE STERILIZATION TRAYS FOR OPHTHALMIC USE is LRP.

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Other records listing Site Microsurgical Systems, 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.

K925828MODIFIED SITE TXR SYSTEMSK925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTEK931866SITE'S CD II PHACOEMULSIFICATION HANDPIECEK921135IOLAB POWER I.V. POLEK920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

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Related Devices (Code: LRP)

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.

K963723LACERATION TRAYGrand Medical ProductsK951811OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACKOsteotech, Inc.K940239EYE TRAYCush Medical ProductsK935621CUSTOM ENT PACKSAssociated MedicalK940646ORTHOPEDIC TRAY PRODUCT LINECushinduK940444GENERAL SURGERY TRAYCush Medical Products

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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