The following data is part of a premarket notification filed by Rao Medical Devices, Inc. with the FDA for In Line Valve Catalog No. 2000a.
| Device ID | K854965 |
| 510k Number | K854965 |
| Device Name: | IN LINE VALVE CATALOG NO. 2000A |
| Classification | Set, Administration, Intravascular |
| Applicant | RAO MEDICAL DEVICES, INC. P.O. BOX 621, 1550 WINCHELL DRIVE Hudson, OH 44236 |
| Contact | Rolf A Oscarsson |
| Correspondent | Rolf A Oscarsson RAO MEDICAL DEVICES, INC. P.O. BOX 621, 1550 WINCHELL DRIVE Hudson, OH 44236 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-11 |
| Decision Date | 1986-02-21 |