The following data is part of a premarket notification filed by Traatek, Inc. with the FDA for Traatek Cottonoid Patties.
| Device ID | K020736 |
| 510k Number | K020736 |
| Device Name: | TRAATEK COTTONOID PATTIES |
| Classification | Neurosurgical Paddie |
| Applicant | TRAATEK, INC. 917 DURISTON RD. Redwood City, CA 94062 |
| Contact | Terry Johnston |
| Correspondent | Terry Johnston TRAATEK, INC. 917 DURISTON RD. Redwood City, CA 94062 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-06 |
| Decision Date | 2002-06-03 |