The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Transducer Protector.
| Device ID | K910821 |
| 510k Number | K910821 |
| Device Name: | TRANSDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Contact | Harwood Green |
| Correspondent | Harwood Green GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-26 |
| Decision Date | 1991-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35034480315107 | K910821 | 000 |