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FDA 510(k)

BIOPSY PUNCH, VARIOUS

K-Number: K841008 · 1984-06-08

ApplicantPremier Dental Products Co.
Decision Date1984-06-08
Product CodeGEE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOPSY PUNCH, VARIOUS is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 1984-06-08 under 510(k) number K841008. The device is classified under product code GEE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY PUNCH, VARIOUS?

BIOPSY PUNCH, VARIOUS is a medical device that received FDA 510(k) clearance on 1984-06-08. The listed applicant is Premier Dental Products Co.. The 510(k) number is K841008.

When did BIOPSY PUNCH, VARIOUS receive FDA 510(k) clearance?

BIOPSY PUNCH, VARIOUS received FDA 510(k) clearance on 1984-06-08, under 510(k) number K841008.

Who is the listed applicant for BIOPSY PUNCH, VARIOUS?

The FDA 510(k) record lists Premier Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPSY PUNCH, VARIOUS?

The FDA product code for BIOPSY PUNCH, VARIOUS is GEE.

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Other records listing Premier Dental Products Co. 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062166ENAMEL PROK062683ENAMEL PRO VARNISHK061998PREMIER SELF-ETCHING BOND ENHANCER

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Related Devices (Code: GEE)

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.

K854003STERILE SOFT TISSUE BIOPSY NEEDLECo-Medical, Inc.K822490DEFLECTING CYTOLOGY BRUSHVan-Tec, Inc.K820259STERILE CYTOLOGY BRUSHESAmerican Endoscopy, Inc.K812694WHISK-RMedi-SpecK801304CAMLOC SYRINGE BIOPSY KITJohannah Medical Services, Inc.K792316TROTEX II SCREW NEEDLE BIOPSY INSTR. SETUrsus Konsult AB

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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