information about
Device Classification Name |
set, administration, intravascular |
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510(k) Number | K002138 | |||
Device Name | PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 | |||
Original Applicant |
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Original Contact | jennifer lyons | |||
Regulation Number | 880.5440 | |||
Classification Product Code |
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Subsequent Product Code |
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Date Received | 07/17/2000 | |||
Decision Date | 08/29/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
General Hospital |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
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Recalls | CDRH Recalls |