The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Ventibox.
| Device ID | K844160 |
| 510k Number | K844160 |
| Device Name: | VENTIBOX |
| Classification | Shield, Protective, Personnel |
| Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Contact | Eleanor V Chiu |
| Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-24 |
| Decision Date | 1984-12-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VENTIBOX 87010790 not registered Dead/Abandoned |
JB & FT Construction Ltd. 2016-04-22 |