The following data is part of a premarket notification filed by Espiner Medical Limited with the FDA for The Espiner Sac Or E Sac.
| Device ID | K111845 |
| 510k Number | K111845 |
| Device Name: | THE ESPINER SAC OR E SAC |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ESPINER MEDICAL LIMITED 116 ALMOND ROAD, CUMBERNAULD Glasgow, GB G673lw |
| Contact | Edwin Lindsay |
| Correspondent | Edwin Lindsay ESPINER MEDICAL LIMITED 116 ALMOND ROAD, CUMBERNAULD Glasgow, GB G673lw |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-29 |
| Decision Date | 2011-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060358120381 | K111845 | 000 |
| 5060358120190 | K111845 | 000 |
| 5060358120206 | K111845 | 000 |
| 5060358120213 | K111845 | 000 |
| 5060358120282 | K111845 | 000 |
| 5060358121289 | K111845 | 000 |
| 5060358121296 | K111845 | 000 |
| 5060358121180 | K111845 | 000 |
| 5060358121197 | K111845 | 000 |
| 5060358121227 | K111845 | 000 |
| 5060358121234 | K111845 | 000 |
| 5060358121333 | K111845 | 000 |
| 5060358120305 | K111845 | 000 |
| 5060358120329 | K111845 | 000 |
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| 5060358120961 | K111845 | 000 |
| 05060358120954 | K111845 | 000 |
| 05060358120961 | K111845 | 000 |
| 5060358120008 | K111845 | 000 |
| 5060358120015 | K111845 | 000 |
| 5060358120022 | K111845 | 000 |
| 5060358120244 | K111845 | 000 |
| 5060358120046 | K111845 | 000 |
| 5060358120053 | K111845 | 000 |
| 5060358120299 | K111845 | 000 |
| 5060358120954 | K111845 | 000 |
| 5060358120084 | K111845 | 000 |
| 5060358120114 | K111845 | 000 |
| 5060358120138 | K111845 | 000 |
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| 5060358120350 | K111845 | 000 |
| 5060358121029 | K111845 | 000 |
| 5060358120671 | K111845 | 000 |
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| 5060358120657 | K111845 | 000 |
| 5060358120664 | K111845 | 000 |
| 5060358120695 | K111845 | 000 |
| 5060358120701 | K111845 | 000 |
| 5060358120572 | K111845 | 000 |
| 5060358120596 | K111845 | 000 |
| 5060358120763 | K111845 | 000 |
| 05060358122286 | K111845 | 000 |
| 05060358122293 | K111845 | 000 |
| 10850346007006 | K111845 | 000 |
| 5060358120633 | K111845 | 000 |
| 5060358121319 | K111845 | 000 |
| 5060358120688 | K111845 | 000 |
| 5060358120367 | K111845 | 000 |
| 5060358121500 | K111845 | 000 |
| 5060358121517 | K111845 | 000 |
| 5060358121524 | K111845 | 000 |
| 5060358120374 | K111845 | 000 |
| 5060358121531 | K111845 | 000 |
| 5060358120404 | K111845 | 000 |
| 5060358120411 | K111845 | 000 |
| 5060358120428 | K111845 | 000 |
| 5060358120435 | K111845 | 000 |
| 5060358120442 | K111845 | 000 |
| 5060358120459 | K111845 | 000 |
| 5060358120602 | K111845 | 000 |
| 10850346007013 | K111845 | 000 |