The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Logic Laparoscopic Scissors.
| Device ID | K063485 |
| 510k Number | K063485 |
| Device Name: | LOGIC LAPAROSCOPIC SCISSORS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGICAL INNOVATIONS PLC CLAYTON PARK CLAYTON WOOD RISE Leeds, GB Ls16 6rf |
| Contact | Stuart Moran |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2006-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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| 14042761072479 | K063485 | 000 |
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| 05051986012940 | K063485 | 000 |