Device Classification Name |
drape, surgical |
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---|---|---|---|---|
510(k) Number | K021864 | |||
Device Name | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) | |||
Original Applicant |
|
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Original Contact | brenda lee | |||
Regulation Number | 878.4370 | |||
Classification Product Code |
|
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Date Received | 06/06/2002 | |||
Decision Date | 09/23/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General & Plastic Surgery |
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510k Review Panel |
General Hospital |
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statement |
statement |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |