The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Nerve Cuff.
| Device ID | K132660 |
| 510k Number | K132660 |
| Device Name: | NERVE CUFF |
| Classification | Cuff, Nerve |
| Applicant | COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Mary A Faderan |
| Correspondent | Mary A Faderan COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2014-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002528045 | K132660 | 000 |
| 00827002527904 | K132660 | 000 |
| 00827002527911 | K132660 | 000 |
| 00827002527928 | K132660 | 000 |
| 00827002528000 | K132660 | 000 |
| 00827002528017 | K132660 | 000 |
| 00827002528024 | K132660 | 000 |
| 00827002528031 | K132660 | 000 |
| 00827002528048 | K132660 | 000 |
| 10827002527895 | K132660 | 000 |
| 10827002527901 | K132660 | 000 |
| 10827002527918 | K132660 | 000 |
| 10827002527925 | K132660 | 000 |
| 10827002528007 | K132660 | 000 |
| 10827002528014 | K132660 | 000 |
| 10827002528021 | K132660 | 000 |
| 10827002528038 | K132660 | 000 |
| 00827002527898 | K132660 | 000 |