The following data is part of a premarket notification filed by Ethitek Pharmaceuticals Co. with the FDA for Administration/manometer Set W/3 Way Stopcock.
| Device ID | K884386 |
| 510k Number | K884386 |
| Device Name: | ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK |
| Classification | Manometer, Blood-pressure, Venous |
| Applicant | ETHITEK PHARMACEUTICALS CO. 8100 N. LAWNDALE AVE. Skokie, IL 60076 |
| Contact | Lionel N Simon |
| Correspondent | Lionel N Simon ETHITEK PHARMACEUTICALS CO. 8100 N. LAWNDALE AVE. Skokie, IL 60076 |
| Product Code | KRK |
| CFR Regulation Number | 870.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1989-01-05 |