The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Codman Surgical Patties & Strips.
| Device ID | K193346 |
| 510k Number | K193346 |
| Device Name: | Codman Surgical Patties & Strips |
| Classification | Neurosurgical Paddie |
| Applicant | Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield, MA 02048 |
| Contact | Alyssa Woodcock |
| Correspondent | Alyssa Woodcock Integra LifeSciences Corporation 11 Cabot Boulevard Mansfield, MA 02048 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-03 |
| Decision Date | 2020-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381780513431 | K193346 | 000 |
| 00381780513417 | K193346 | 000 |
| 00381780513370 | K193346 | 000 |
| 00381780513462 | K193346 | 000 |
| 40198459122669 | K193346 | 000 |
| 40198459122652 | K193346 | 000 |
| 40198459122645 | K193346 | 000 |
| 40198459122638 | K193346 | 000 |