The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Tsh Ria.
Device ID | K833910 |
510k Number | K833910 |
Device Name: | TSH RIA |
Classification | Tube, Tympanostomy |
Applicant | SYNCOR INTL. CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ETD |
CFR Regulation Number | 874.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-14 |
Decision Date | 1983-11-22 |