The following data is part of a premarket notification filed by Circulatory Technology, Inc. with the FDA for Better-bladder (bb).
| Device ID | K964337 |
| 510k Number | K964337 |
| Device Name: | BETTER-BLADDER (BB) |
| Classification | Protector, Transducer, Dialysis |
| 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 | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1997-05-23 |