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FDA 510(k)

SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES

K-Number: K071203 · 2007-06-13

ApplicantOptikem International, Inc.
Decision Date2007-06-13
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Optikem International, Inc.. It received FDA 510(k) clearance on 2007-06-13 under 510(k) number K071203. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES?

SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2007-06-13. The listed applicant is Optikem International, Inc.. The 510(k) number is K071203.

When did SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES receive FDA 510(k) clearance?

SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES received FDA 510(k) clearance on 2007-06-13, under 510(k) number K071203.

Who is the listed applicant for SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES?

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

What is the FDA product code for SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES?

The FDA product code for SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES is LPN.

Related Clinical Trials

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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Other records listing Optikem International, 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.

K822495LE CASE HARD CONTACT LENS STORAGE CASE

Related Devices (Code: LPN)

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

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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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