The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for # 9455 And #9457 Poole Tip Suction Probe.
| Device ID | K923908 |
| 510k Number | K923908 |
| Device Name: | # 9455 AND #9457 POOLE TIP SUCTION PROBE |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Contact | John Mayall |
| Correspondent | John Mayall O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-04 |
| Decision Date | 1993-05-17 |