The following data is part of a premarket notification filed by Circulatory Technology, Inc. with the FDA for Better-bladder (bb).
| Device ID | K981284 |
| 510k Number | K981284 |
| Device Name: | BETTER-BLADDER (BB) |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Contact | Yehuda Tamari |
| Correspondent | Yehuda Tamari CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-08 |
| Decision Date | 1998-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851997007011 | K981284 | 000 |
| 00851997007004 | K981284 | 000 |