The following data is part of a premarket notification filed by American V. Mueller with the FDA for Heyer-schulte(r) One Piece Shunt Vent. Cath. Intro.
| Device ID | K873771 |
| 510k Number | K873771 |
| Device Name: | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO |
| Classification | Instrument, Shunt System Implantation |
| Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
| Contact | Matthew Nowland |
| Correspondent | Matthew Nowland AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-16 |
| Decision Date | 1987-12-18 |