The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Stopcocks & Extension Tubes.
| Device ID | K840394 |
| 510k Number | K840394 |
| Device Name: | STOPCOCKS & EXTENSION TUBES |
| Classification | Stopcock, I.v. Set |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-30 |
| Decision Date | 1984-03-19 |