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FDA 510(k)

BIOPSER

K-Number: K820519 · 1982-04-29

ApplicantAdvanced Biomedical Instruments
Decision Date1982-04-29
Product CodeHFB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIOPSER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Instruments. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K820519. The device is classified under product code HFB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSER?

BIOPSER is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Advanced Biomedical Instruments. The 510(k) number is K820519.

When did BIOPSER receive FDA 510(k) clearance?

BIOPSER received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820519.

Who is the listed applicant for BIOPSER?

The FDA 510(k) record lists Advanced Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPSER?

The FDA product code for BIOPSER is HFB.

Related Clinical Trials

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Other records listing Advanced Biomedical Instruments 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.

K843156BIOLAS YAG 100 CILAS, ERCELAS YAG 100K842670BIOLAS YAG 100K801197CO2 LASER

Related Devices (Code: HFB)

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.

K011488SPIRABRUSH CX BIOPSY INSTRUMENTTrylon Corp.K944444CIT BIOPSY PUNCHESChirurgische InstrumenteK930773SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPSSymbiosis Corp.K933767FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSYMahe-MedizintechnikK926595OWENS BIOPSY FORCEPSOwens Industries, Inc.K926527ROTO FIT BIOPSY FORCEPSThomasville Medical Assoc.

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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