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FDA 510(k)

MINUTEMAN CO2 MICROSURGICAL LASER GYN

K-Number: K843515 · 1985-02-04

ApplicantAmerican Surgical Laser, Inc.
Decision Date1985-02-04
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MINUTEMAN CO2 MICROSURGICAL LASER GYN 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 1985-02-04 under 510(k) number K843515. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINUTEMAN CO2 MICROSURGICAL LASER GYN?

MINUTEMAN CO2 MICROSURGICAL LASER GYN is a medical device that received FDA 510(k) clearance on 1985-02-04. The listed applicant is American Surgical Laser, Inc.. The 510(k) number is K843515.

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

MINUTEMAN CO2 MICROSURGICAL LASER GYN received FDA 510(k) clearance on 1985-02-04, under 510(k) number K843515.

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

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 GYN?

The FDA product code for MINUTEMAN CO2 MICROSURGICAL LASER GYN is HHR.

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.

K843517MINUTEMAN CO2 MICROSURG LASER DERMATOL-K843519MINUTEMAN CO2 MICROSURG LASER GEN SURGK843518MINUTEMAN C02 MICROSURG LASER PODIATRYK843514MINUTEMAN CO2 MICROSURGICAL LASER OTO

Related Devices (Code: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, Inc.

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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