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FDA 510(k)

CARBON DIOXIDE LASER ML 825

K-Number: K833528 · 1985-02-19

ApplicantMerrimack Laboratories
Decision Date1985-02-19
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE LASER ML 825 is the device name listed in this FDA 510(k) record. The listed applicant is Merrimack Laboratories. It received FDA 510(k) clearance on 1985-02-19 under 510(k) number K833528. 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 CARBON DIOXIDE LASER ML 825?

CARBON DIOXIDE LASER ML 825 is a medical device that received FDA 510(k) clearance on 1985-02-19. The listed applicant is Merrimack Laboratories. The 510(k) number is K833528.

When did CARBON DIOXIDE LASER ML 825 receive FDA 510(k) clearance?

CARBON DIOXIDE LASER ML 825 received FDA 510(k) clearance on 1985-02-19, under 510(k) number K833528.

Who is the listed applicant for CARBON DIOXIDE LASER ML 825?

The FDA 510(k) record lists Merrimack Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARBON DIOXIDE LASER ML 825?

The FDA product code for CARBON DIOXIDE LASER ML 825 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Merrimack Laboratories 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.

K833483ENDOSCOPIC COUPLERK827963MODEL ML-850K827506MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERYK827442ML-810 CARBON DIOXIDE LASER SYSTEMK800227ML-800 CO2

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

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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