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 |