The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Nerve Cuff.
| Device ID | K031069 |
| 510k Number | K031069 |
| Device Name: | SURGISIS NERVE CUFF |
| Classification | Cuff, Nerve |
| Applicant | COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Contact | Mark Bleyer |
| Correspondent | Mark Bleyer COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-04 |
| Decision Date | 2003-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002527994 | K031069 | 000 |
| 00827002527980 | K031069 | 000 |
| 00827002527973 | K031069 | 000 |
| 00827002527966 | K031069 | 000 |
| 00827002527959 | K031069 | 000 |
| 00827002527942 | K031069 | 000 |
| 00827002527935 | K031069 | 000 |
| 00827002351356 | K031069 | 000 |
| 00827002351349 | K031069 | 000 |
| 00827002351332 | K031069 | 000 |
| 00827002351325 | K031069 | 000 |
| 00827002351318 | K031069 | 000 |
| 00827002351301 | K031069 | 000 |
| 00827002527997 | K031069 | 000 |
| 10827002351285 | K031069 | 000 |
| 10827002527987 | K031069 | 000 |
| 10827002527970 | K031069 | 000 |
| 10827002527963 | K031069 | 000 |
| 10827002527956 | K031069 | 000 |
| 10827002527949 | K031069 | 000 |
| 10827002527932 | K031069 | 000 |
| 10827002351353 | K031069 | 000 |
| 10827002351346 | K031069 | 000 |
| 10827002351339 | K031069 | 000 |
| 10827002351322 | K031069 | 000 |
| 10827002351315 | K031069 | 000 |
| 10827002351308 | K031069 | 000 |
| 00827002351288 | K031069 | 000 |