The following data is part of a premarket notification filed by Galvin Industries, Inc. with the FDA for Tranducer Protector.
| Device ID | K851428 |
| 510k Number | K851428 |
| Device Name: | TRANDUCER PROTECTOR |
| Classification | Protector, Transducer, Dialysis |
| Applicant | GALVIN INDUSTRIES, INC. 828 WEST 24TH ST. Tempe, AZ 85282 |
| Contact | Jay M Galvin |
| Correspondent | Jay M Galvin GALVIN INDUSTRIES, INC. 828 WEST 24TH ST. Tempe, AZ 85282 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-10 |
| Decision Date | 1985-05-21 |