The following data is part of a premarket notification filed by Rao Medical Devices, Inc. with the FDA for Tubing Clamp Cat#1000-a.
| Device ID | K854512 |
| 510k Number | K854512 |
| Device Name: | TUBING CLAMP CAT#1000-A |
| Classification | Clamp, Line |
| 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 | FKK |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1985-12-02 |