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FDA 510(k)

OCU-FILM TIP COVER

K-Number: K882750 · 1988-08-04

ApplicantOculab, Inc.
Decision Date1988-08-04
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCU-FILM TIP COVER is the device name listed in this FDA 510(k) record. The listed applicant is Oculab, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K882750. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCU-FILM TIP COVER?

OCU-FILM TIP COVER is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Oculab, Inc.. The 510(k) number is K882750.

When did OCU-FILM TIP COVER receive FDA 510(k) clearance?

OCU-FILM TIP COVER received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882750.

Who is the listed applicant for OCU-FILM TIP COVER?

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

What is the FDA product code for OCU-FILM TIP COVER?

The FDA product code for OCU-FILM TIP COVER is HKY.

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Other records listing Oculab, 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.

K884619PACH-PEN CALCULATORK862016PACH-PEN SURGICAL DRAPEK860205BIO-PEN CALCULATORK860061OCULAB BIOMETRICPENK860062OCULAB PACHPENK852774OCULAB TONOPEN

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Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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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