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FDA 510(k)

OLSEN 756 ROCKER SWITCHPEN

K-Number: K834329 · 1984-04-04

ApplicantOlsen Electro-Surgical Instruments, Inc.
Decision Date1984-04-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OLSEN 756 ROCKER SWITCHPEN is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Electro-Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K834329. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLSEN 756 ROCKER SWITCHPEN?

OLSEN 756 ROCKER SWITCHPEN is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Olsen Electro-Surgical Instruments, Inc.. The 510(k) number is K834329.

When did OLSEN 756 ROCKER SWITCHPEN receive FDA 510(k) clearance?

OLSEN 756 ROCKER SWITCHPEN received FDA 510(k) clearance on 1984-04-04, under 510(k) number K834329.

Who is the listed applicant for OLSEN 756 ROCKER SWITCHPEN?

The FDA 510(k) record lists Olsen Electro-Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLSEN 756 ROCKER SWITCHPEN?

The FDA product code for OLSEN 756 ROCKER SWITCHPEN is GEI.

Related Clinical Trials

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Other records listing Olsen Electro-Surgical Instruments, 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.

K834410DOUBLE-COAGULATION SWITCHPEN 757K820158OLSEN #770 DISPOSABLE HOLSTER

Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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