The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for Wound Protector.
| Device ID | K120061 |
| 510k Number | K120061 |
| Device Name: | WOUND PROTECTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Contact | Joseph Canavan |
| Correspondent | Joseph Canavan COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2012-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521164816 | K120061 | 000 |
| 30884521164837 | K120061 | 000 |
| 30884521164820 | K120061 | 000 |