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FDA 510(k)

450/800 DRILL

K-Number: K812436 · 1981-11-02

ApplicantBlack & Decker(Tm)
Decision Date1981-11-02
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

450/800 DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Black & Decker(Tm). It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812436. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 450/800 DRILL?

450/800 DRILL is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Black & Decker(Tm). The 510(k) number is K812436.

When did 450/800 DRILL receive FDA 510(k) clearance?

450/800 DRILL received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812436.

Who is the listed applicant for 450/800 DRILL?

The FDA 510(k) record lists Black & Decker(Tm) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 450/800 DRILL?

The FDA product code for 450/800 DRILL is HBC.

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Other records listing Black & Decker(Tm) 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.

K820351CAST CUTTER/CAST SAW/INSTRUMENTK812437150 DRIVER REAMERK812440POWER PACKK812439DUAL MPC CHARGERK812438SAGITTAL SAWK800314POWER PACK

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Related Devices (Code: HBC)

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.

K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.

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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