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 |