The following data is part of a premarket notification filed by Covidien with the FDA for Surgisleeve Wound Protector.
| Device ID | K140064 |
| 510k Number | K140064 |
| Device Name: | SURGISLEEVE WOUND PROTECTOR |
| Classification | Drape, Surgical |
| Applicant | COVIDIEN 60 MIDDLETOWN DR North Haven, CT 06473 |
| Contact | Michael Koczocik |
| Correspondent | Michael Koczocik COVIDIEN 60 MIDDLETOWN DR North Haven, CT 06473 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-10 |
| Decision Date | 2014-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521203792 | K140064 | 000 |