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FDA 510(k)

LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD

K-Number: K884362 · 1988-11-29

ApplicantBausch & Lomb Pharmaceutical, Inc.
Decision Date1988-11-29
Product CodeHQJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb Pharmaceutical, Inc.. It received FDA 510(k) clearance on 1988-11-29 under 510(k) number K884362. The device is classified under product code HQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD?

LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD is a medical device that received FDA 510(k) clearance on 1988-11-29. The listed applicant is Bausch & Lomb Pharmaceutical, Inc.. The 510(k) number is K884362.

When did LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD receive FDA 510(k) clearance?

LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD received FDA 510(k) clearance on 1988-11-29, under 510(k) number K884362.

Who is the listed applicant for LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD?

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

What is the FDA product code for LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD?

The FDA product code for LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD is HQJ.

Related Clinical Trials

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Other records listing Bausch & Lomb Pharmaceutical, 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.

K884962ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEAK884960ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEALK884961ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEALK884363LABELING CHANGES TO BIO-COR II COLLANGEN CORNEALK884364LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL

Related Devices (Code: HQJ)

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.

K896350TITAN AIR SPECTACLE FRAMEAcces Intl. EyewearK875014LABTICIAN RETINAL IMPLANTSLabtician Products, Inc.K831773MAI HYDROSEAL IMPLANT FOR SCLERAL BUCKBcd Products, Inc.K760550IMPLANT, SILICONE AND TANTALUMMedical Instrument Research Assoc., Inc.

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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