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FDA 510(k)

DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)

K-Number: K971342 · 1997-07-08

Decision Date1997-07-08
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) is the device name listed in this FDA 510(k) record. The listed applicant is Disk Whisk, Inc.. It received FDA 510(k) clearance on 1997-07-08 under 510(k) number K971342. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)?

DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) is a medical device that received FDA 510(k) clearance on 1997-07-08. The listed applicant is Disk Whisk, Inc.. The 510(k) number is K971342.

When did DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) receive FDA 510(k) clearance?

DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) received FDA 510(k) clearance on 1997-07-08, under 510(k) number K971342.

Who is the listed applicant for DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)?

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

What is the FDA product code for DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)?

The FDA product code for DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) is HWE.

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.

Related Devices (Code: HWE)

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.

Official Source

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