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FDA 510(k)

MORGAN SUTURE-DRILL

K-Number: K853376 · 1985-11-13

ApplicantBowen & Company, Inc.
Decision Date1985-11-13
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MORGAN SUTURE-DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Bowen & Company, Inc.. It received FDA 510(k) clearance on 1985-11-13 under 510(k) number K853376. 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 MORGAN SUTURE-DRILL?

MORGAN SUTURE-DRILL is a medical device that received FDA 510(k) clearance on 1985-11-13. The listed applicant is Bowen & Company, Inc.. The 510(k) number is K853376.

When did MORGAN SUTURE-DRILL receive FDA 510(k) clearance?

MORGAN SUTURE-DRILL received FDA 510(k) clearance on 1985-11-13, under 510(k) number K853376.

Who is the listed applicant for MORGAN SUTURE-DRILL?

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

What is the FDA product code for MORGAN SUTURE-DRILL?

The FDA product code for MORGAN SUTURE-DRILL is HWE.

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Other records listing Bowen & Company, Inc. as applicant

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K896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERK896538DISPOSABLE 45 DEGREE SHAVERK873766STERNAL POWER AWLK872098CREMEEN ALVEOLAR BONE CALIPERK871325BOWEN REUSEABLE/DISPOSABLE ELECTRODEK87088245 DEGREE SHAVER

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Related Devices (Code: HWE)

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K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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