The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Cook Gastric Sizing Balloon Catheter.
| Device ID | K030841 |
| 510k Number | K030841 |
| Device Name: | COOK GASTRIC SIZING BALLOON CATHETER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 -0489 |
| Contact | Carol Zwissler |
| Correspondent | Carol Zwissler COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 -0489 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-17 |
| Decision Date | 2003-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002302747 | K030841 | 000 |