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FDA 510(k)

SURGICAL RETRACTORS-VARIOUS

K-Number: K841009 · 1984-05-01

ApplicantPremier Dental Products Co.
Decision Date1984-05-01
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL RETRACTORS-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 1984-05-01 under 510(k) number K841009. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL RETRACTORS-VARIOUS?

SURGICAL RETRACTORS-VARIOUS is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Premier Dental Products Co.. The 510(k) number is K841009.

When did SURGICAL RETRACTORS-VARIOUS receive FDA 510(k) clearance?

SURGICAL RETRACTORS-VARIOUS received FDA 510(k) clearance on 1984-05-01, under 510(k) number K841009.

Who is the listed applicant for SURGICAL RETRACTORS-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 SURGICAL RETRACTORS-VARIOUS?

The FDA product code for SURGICAL RETRACTORS-VARIOUS is GAD.

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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 PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK062166ENAMEL PROK061998PREMIER SELF-ETCHING BOND ENHANCER

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Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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