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FDA 510(k)

PENN 3-RING HANDLE

K-Number: K862729 · 1986-10-24

ApplicantPenn Medical Devices, Inc.
Decision Date1986-10-24
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENN 3-RING HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Penn Medical Devices, Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K862729. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENN 3-RING HANDLE?

PENN 3-RING HANDLE is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Penn Medical Devices, Inc.. The 510(k) number is K862729.

When did PENN 3-RING HANDLE receive FDA 510(k) clearance?

PENN 3-RING HANDLE received FDA 510(k) clearance on 1986-10-24, under 510(k) number K862729.

Who is the listed applicant for PENN 3-RING HANDLE?

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

What is the FDA product code for PENN 3-RING HANDLE?

The FDA product code for PENN 3-RING HANDLE is FFL.

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Other records listing Penn Medical Devices, 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.

K873949RORERTAZZI NASOPHARYNGEAL AIRWAYK873177DEVINE (SUPRAPUBIC SOUND AND GUIDE)K873176HUFFMAN BIOPSY UNITK873178URETERAL BULB DILATORSK871667URETERAL STENTK870508GASTROINTESTINAL TUBE

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Related Devices (Code: FFL)

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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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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