The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Chito-seal.
| Device ID | K021062 |
| 510k Number | K021062 |
| Device Name: | CHITO-SEAL |
| Classification | Dressing, Wound, Drug |
| Applicant | ABBOTT VASCULAR INC. 400 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Sevrina Ciucci |
| Correspondent | Sevrina Ciucci ABBOTT VASCULAR INC. 400 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-02 |
| Decision Date | 2002-08-23 |
| Summary: | summary |