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FDA 510(k)

VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT

K-Number: K934014 · 1995-12-06

ApplicantBiotrol, USA, Inc.
Decision Date1995-12-06
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K934014. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT?

VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K934014.

When did VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT receive FDA 510(k) clearance?

VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT received FDA 510(k) clearance on 1995-12-06, under 510(k) number K934014.

Who is the listed applicant for VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT?

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

What is the FDA product code for VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT?

The FDA product code for VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT is LRJ. This falls under the Clinical Lab category.

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Other records listing Biotrol, USA, 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.

K931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDSK905683BIOTROL LACTATE DEHYDROGENASE (L-P)

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Related Devices (Code: LRJ)

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.

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, 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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