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File: /var/www/fda.report/application/controllers/Pmn.php
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Function: __construct
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File: /var/www/fda.report/pmn_item.php
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Filename: drivers/Session_files_driver.php
Line Number: 384
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File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
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Function: require_once
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Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
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Function: require_once
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Filename: drivers/Session_files_driver.php
Line Number: 384
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File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
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Function: include
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Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
Severity: Warning
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Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pmn.php
Line: 8
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pmn_item.php
Line: 11
Function: include
The following data is part of a premarket notification filed by Endovations with the FDA for Enteron Abdominal Paracentesis Tray.
| Device ID | K874063 |
| 510k Number | K874063 |
| Device Name: | ENTERON ABDOMINAL PARACENTESIS TRAY |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Susan P Bjorkman |
| Correspondent | Susan P Bjorkman ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1987-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902077081 | K874063 | 000 |
| 40801902120104 | K874063 | 000 |
| 30801902130236 | K874063 | 000 |
| 40801902120180 | K874063 | 000 |
| 20801902145813 | K874063 | 000 |
| 20801902130239 | K874063 | 000 |
| 30801902120107 | K874063 | 000 |
| 40801902004770 | K874063 | 000 |
| 60801902120108 | K874063 | 000 |
| 30801902004773 | K874063 | 000 |
| 20801902004776 | K874063 | 000 |