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FDA 510(k)

STERILE EYE SURGERY KITS

K-Number: K842990 · 1985-05-09

ApplicantBiological & Environmental Control Laboratories
Decision Date1985-05-09
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STERILE EYE SURGERY KITS is the device name listed in this FDA 510(k) record. The listed applicant is Biological & Environmental Control Laboratories. It received FDA 510(k) clearance on 1985-05-09 under 510(k) number K842990. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE EYE SURGERY KITS?

STERILE EYE SURGERY KITS is a medical device that received FDA 510(k) clearance on 1985-05-09. The listed applicant is Biological & Environmental Control Laboratories. The 510(k) number is K842990.

When did STERILE EYE SURGERY KITS receive FDA 510(k) clearance?

STERILE EYE SURGERY KITS received FDA 510(k) clearance on 1985-05-09, under 510(k) number K842990.

Who is the listed applicant for STERILE EYE SURGERY KITS?

The FDA 510(k) record lists Biological & Environmental Control Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE EYE SURGERY KITS?

The FDA product code for STERILE EYE SURGERY KITS is HOZ.

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Other records listing Biological & Environmental Control Laboratories as applicant

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Related Devices (Code: HOZ)

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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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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