Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- LDKDevice, Sensing, Optical ContourUProduct Code
- LWBStimulator, Functional Neuromuscular, Scoliosis3Product Code
- LXMManipulator, Plunger-Like JointUProduct Code
- LZWMonitor, Spine CurvatureUProduct Code
- MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing3Product Code
- MLYVapocoolant DeviceUProduct Code
- K243654DentalJectUCleared 510(K)
- K232674PainFreeze IIUCleared 510(K)
- K203661CRYO Arctic, CRYO PenguinUCleared 510(K)
- K202782num VapocoolantUCleared 510(K)
- K201248Syringe Holder accessoryUCleared 510(K)
- K193349Vapocoolshot MistUCleared 510(K)
- K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayUCleared 510(K)
- K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREEUCleared 510(K)
- K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)UCleared 510(K)
- K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayUCleared 510(K)
- K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102UCleared 510(K)
- K093951OUCHLESS MODEL PN10114UCleared 510(K)
- K033720ARI COLD SPRAYUCleared 510(K)
- K032671GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07UCleared 510(K)
- K030281CRYOTRON 2 CRYOTHERAPY DEVICEUCleared 510(K)
- K031036GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03UCleared 510(K)
- K021726GEBAUER'S INSTANT ICEUCleared 510(K)
- K002596GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09UCleared 510(K)
- K001624GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04UCleared 510(K)
- K992286DERMAFREEZEUCleared 510(K)
- K984564ETHYL CHLORIDE DISPENSERUCleared 510(K)
- K991514GEBAUER'S CHLORIDE FINE NOZZEUCleared 510(K)
- K930915FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICEUCleared 510(K)
- QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation3Product Code
- QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms2Product Code
- SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation2Product Code
- SECWearable Fall Injury Prevention Device2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
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DERMAFREEZE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K992286
- 510(k) Type
- Traditional
- Applicant
- RHEALM PHARMACEUTICALS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/21/2000
- Days to Decision
- 198 days
- Submission Type
- Statement