Device Classification Name |
laparoscope, general & plastic surgery |
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---|---|---|---|---|
510(k) Number | K992182 | |||
Device Name | CA GUARD, LTD. PSP (PORT SITE PROTECTOR) | |||
Applicant |
|
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Applicant Contact | frank m lewis | |||
Correspondent |
|
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Correspodent Contact | frank m lewis | |||
Regulation Number | 876.1500 | |||
Classification Product Code |
|
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Date Received | 06/28/1999 | |||
Decision Date | 07/18/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Gastroenterology/Urology |
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510k Review Panel |
General & Plastic Surgery |
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statement |
statement |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |