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FDA 510(k)

DRILL GUIDE

K-Number: K841619 · 1984-07-11

ApplicantPlastafil, Inc.
Decision Date1984-07-11
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRILL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Plastafil, Inc.. It received FDA 510(k) clearance on 1984-07-11 under 510(k) number K841619. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRILL GUIDE?

DRILL GUIDE is a medical device that received FDA 510(k) clearance on 1984-07-11. The listed applicant is Plastafil, Inc.. The 510(k) number is K841619.

When did DRILL GUIDE receive FDA 510(k) clearance?

DRILL GUIDE received FDA 510(k) clearance on 1984-07-11, under 510(k) number K841619.

Who is the listed applicant for DRILL GUIDE?

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 DRILL GUIDE?

The FDA product code for DRILL GUIDE is FZX.

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: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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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