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FDA 510(k)

MINUTEMAN CO2 MICROSURGICAL LASER OTO

K-Number: K843514 · 1984-12-04

ApplicantAmerican Surgical Laser, Inc.
Decision Date1984-12-04
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MINUTEMAN CO2 MICROSURGICAL LASER OTO is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Laser, Inc.. It received FDA 510(k) clearance on 1984-12-04 under 510(k) number K843514. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINUTEMAN CO2 MICROSURGICAL LASER OTO?

MINUTEMAN CO2 MICROSURGICAL LASER OTO is a medical device that received FDA 510(k) clearance on 1984-12-04. The listed applicant is American Surgical Laser, Inc.. The 510(k) number is K843514.

When did MINUTEMAN CO2 MICROSURGICAL LASER OTO receive FDA 510(k) clearance?

MINUTEMAN CO2 MICROSURGICAL LASER OTO received FDA 510(k) clearance on 1984-12-04, under 510(k) number K843514.

Who is the listed applicant for MINUTEMAN CO2 MICROSURGICAL LASER OTO?

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

What is the FDA product code for MINUTEMAN CO2 MICROSURGICAL LASER OTO?

The FDA product code for MINUTEMAN CO2 MICROSURGICAL LASER OTO is EWG.

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 American Surgical Laser, 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.

K843515MINUTEMAN CO2 MICROSURGICAL LASER GYNK843517MINUTEMAN CO2 MICROSURG LASER DERMATOL-K843519MINUTEMAN CO2 MICROSURG LASER GEN SURGK843518MINUTEMAN C02 MICROSURG LASER PODIATRY

Related Devices (Code: EWG)

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.

K924652BENSON CCA100Benson Medical Instruments Co.K870587LASERMATIC SURGILASER MODEL 5050Lasermatic OYK880429ILLUMINA 55 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, 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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