The following data is part of a premarket notification filed by United Pharmaceutical And Medical Supply Co. with the FDA for Transducer Protector.
Device ID | K915593 |
510k Number | K915593 |
Device Name: | TRANSDUCER PROTECTOR |
Classification | Protector, Transducer, Dialysis |
Applicant | UNITED PHARMACEUTICAL AND MEDICAL SUPPLY CO. 2921 TELEGRAPH AVE. Berkeley, CA 94705 |
Contact | Thomas Cane |
Correspondent | Thomas Cane UNITED PHARMACEUTICAL AND MEDICAL SUPPLY CO. 2921 TELEGRAPH AVE. Berkeley, CA 94705 |
Product Code | FIB |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-13 |
Decision Date | 1992-07-01 |