The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Pms Amniocentesis Tray/kit.
| Device ID | K850632 |
| 510k Number | K850632 |
| Device Name: | PMS AMNIOCENTESIS TRAY/KIT |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Contact | James E Williams |
| Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-05-22 |