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510(k) Data Aggregation

    K Number
    K984270
    Device Name
    VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
    Manufacturer
    ROGER L. GOODMAN, D.D.S., P.C.
    Date Cleared
    1999-05-20

    (171 days)

    Product Code
    MED, 80M
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROGER L. GOODMAN, D.D.S., P.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vapo Solution™ is an alcohol solution intended to be used only in Harvey Chemiclave sterilizers to sterilize medical and dental surgical instrument. Vapo Solution™ is intended to be a direct substitute for Vapo-Steril®. Vapo Solution™ is recommended for use in the following Chemiclave models: 4000, 5500, 6000 and models covered under K924380 and K943654. Vapo Solution™ is compatible with Chemiclave cycle parameters as follows: - Model 4000, 5000, 5500, 6000, EM5000, EM5500, and EM6000 - Operating pressure: 20-40 psi (1.41 2.82 kg/cm²) - Operating Temperature: 132 +2 ℃ (270 + 5 0r) - Maximum load: Bagged instruments: - 6" Chamber (models 4000, 5000, EM5000) 0.6 Kg (1.3 lbs) - 8" Chamber (models 5500, EM5500) 1.2 Kg (2.6 lbs) - 10" Chamber (models 6000, EM6000) 2.4 Kg (5.3 lbs) - Maximum load: Unwrapped instruments: - 6" Chamber (models 4000, 5000, EM5000) 0.75 Kg (1.7 lbs) - 8" Chamber (models 5500, EM5500) 1.4 Kg (3.1 lbs) - 10" Chamber (models 6000, EM6000) 2.8 Kg (6.2 lbs) - Model 7000 and 8000 - Operating pressure: approximately 25 psi - Operating Temperature: 132 ± 2°C (270 ±5°F) - Maximum load: Bagged instruments: - 8" Chamber (model 7000) 1.2 Kg (2.6 lbs) - 10" Chamber (model 8000) 2.4 Kg (5.3 lbs) - Maximum load: Unwrapped instruments: - 8" Chamber (model 7000) 1.4 Kg (3.1 lbs) - 10" Chamber (model 8000) 2.8 Kg (6.2 lbs) Vapo Solution™ is compatible with but not limited to the following instruments and material types: - Surgical and cutting instruments, handpieces, and similar items. - Plastics that can tolerate in excess of 132 °C. i.e. Polysulfone, Phenolic, Nylon, Teflon, Polyethylene, Polyacetal, Polypropylene. Note: Polycarbonate is not chemically compatible. - Rubber components made of Silicone, Fluorosilicone Vapo Solution™ is not compatible with the following materials: - Linen, textiles or fabrics These are incompatible with the chemical vapor process. - Liquids and agars These are incompatible with high temperature processing (132°C). - Items contained in tightly woven packs or wraps, or sealed containers These cause poor vapor penetration. - Plastics which cannot tolerate temperatures in excess of 132ºC. - Polycarbonate - Chemically incompatible. - Nylon tubing and bags Inhibits penetration of chemical vapors. Vapo Solution™ is not recommended for use for "flash" sterilization cycles.
    Device Description
    A specific solution of various alcohols, acetone, ketone, formaldehyde, and distilled water for use only in MDT Harvey Chemiclave® sterilizers.
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