The following data is part of a premarket notification filed by Tico Medical Instruments, Inc. with the FDA for Dialysis Trandsducer Protector.
| Device ID | K911658 |
| 510k Number | K911658 |
| Device Name: | DIALYSIS TRANDSDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | TICO MEDICAL INSTRUMENTS, INC. 3600 STATE RD 520 P.O. BOX 3823 COCOA, FL 32926 |
| Contact | E. J SIMICICH |
| Correspondent | E. J SIMICICH TICO MEDICAL INSTRUMENTS, INC. 3600 STATE RD 520 P.O. BOX 3823 COCOA, FL 32926 |
| Product Code | FIB |
| Subsequent Product Code | New |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-12 |
| Decision Date | 1991-08-12 |