Device Classification Name |
stimulator, muscle, powered |
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---|---|---|---|---|
510(k) Number | K021100 | |||
Device Name | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | |||
Original Applicant |
|
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Original Contact | sheila hemeon-heyer | |||
Regulation Number | 890.5850 | |||
Classification Product Code |
|
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Subsequent Product Codes |
|
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Date Received | 04/04/2002 | |||
Decision Date | 06/18/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Physical Medicine |
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510k Review Panel |
Neurology |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |