The following data is part of a premarket notification filed by Akron Catheter, Inc. with the FDA for Akro-sil Plus.
| Device ID | K864736 |
| 510k Number | K864736 |
| Device Name: | AKRO-SIL PLUS |
| Classification | Catheter, Urological |
| Applicant | AKRON CATHETER, INC. P.O. BOX 5356 Akron, OH 44313 |
| Contact | Marjorie Skinner |
| Correspondent | Marjorie Skinner AKRON CATHETER, INC. P.O. BOX 5356 Akron, OH 44313 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-04 |
| Decision Date | 1986-12-24 |