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FDA 510(k)

MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK

K-Number: K831773 · 1983-08-16

ApplicantBcd Products, Inc.
Decision Date1983-08-16
Product CodeHQJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK is the device name listed in this FDA 510(k) record. The listed applicant is Bcd Products, Inc.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K831773. 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 MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK?

MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Bcd Products, Inc.. The 510(k) number is K831773.

When did MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK receive FDA 510(k) clearance?

MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK received FDA 510(k) clearance on 1983-08-16, under 510(k) number K831773.

Who is the listed applicant for MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK?

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

What is the FDA product code for MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK?

The FDA product code for MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK is HQJ.

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 Bcd Products, 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.

K813547THERMASCAN

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. EyewearK884362LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLDBausch & Lomb Pharmaceutical, Inc.K875014LABTICIAN RETINAL IMPLANTSLabtician Products, Inc.K760550IMPLANT, SILICONE AND TANTALUMMedical Instrument Research Assoc., Inc.

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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