FDA 510(k)

PROMED 55-G SOFT DAILY WEAR CONTACT LENS

K-Number: K970615 · 1997-03-19

Decision Date1997-03-19

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PROMED 55-G SOFT DAILY WEAR CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Biomed Devices Corp.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K970615. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROMED 55-G SOFT DAILY WEAR CONTACT LENS?

PROMED 55-G SOFT DAILY WEAR CONTACT LENS is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Biomed Devices Corp.. The 510(k) number is K970615.

When did PROMED 55-G SOFT DAILY WEAR CONTACT LENS receive FDA 510(k) clearance?

PROMED 55-G SOFT DAILY WEAR CONTACT LENS received FDA 510(k) clearance on 1997-03-19, under 510(k) number K970615.

Who is the listed applicant for PROMED 55-G SOFT DAILY WEAR CONTACT LENS?

The FDA 510(k) record lists Biomed Devices Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROMED 55-G SOFT DAILY WEAR CONTACT LENS?

The FDA product code for PROMED 55-G SOFT DAILY WEAR CONTACT LENS is LPL.

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Other records listing Biomed Devices Corp. as applicant

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Related Devices (Code: LPL)

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.