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FDA 510(k)

MALLET

K-Number: K841627 · 1984-08-27

ApplicantPlastafil, Inc.
Decision Date1984-08-27
Product CodeHWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MALLET is the device name listed in this FDA 510(k) record. The listed applicant is Plastafil, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K841627. The device is classified under product code HWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALLET?

MALLET is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Plastafil, Inc.. The 510(k) number is K841627.

When did MALLET receive FDA 510(k) clearance?

MALLET received FDA 510(k) clearance on 1984-08-27, under 510(k) number K841627.

Who is the listed applicant for MALLET?

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

What is the FDA product code for MALLET?

The FDA product code for MALLET is HWA.

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.

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Other records listing Plastafil, Inc. 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.

K841621BACK RADIUS CUTTERK841620FRONT RADIUS CUTTERK841625HOOKK841617STROVER HOOKK841626PUNCHK841629DRILL BIT

View all 13 devices →

Related Devices (Code: HWA)

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.

K933527MODIFICATION OF ANTERIOR SEGMENT ELECTRODESMira, Inc.K864422RAYLOR(TM) MALLETCedar Surgical, Inc.K770205CEMENT CHISELSDepuy, Inc.

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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