Device Classification Name |
thermometer, electronic, clinical |
|||
---|---|---|---|---|
510(k) Number | K991914 | |||
Device Name | SUPER SOOTHER | |||
Applicant |
|
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Applicant Contact | jimmy dong | |||
Correspondent |
|
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Correspodent Contact | jimmy dong | |||
Regulation Number | 880.2910 | |||
Classification Product Code |
|
|||
Date Received | 06/07/1999 | |||
Decision Date | 10/06/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
General Hospital |
|||
statement |
statement |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |