The following data is part of a premarket notification filed by Latex Ind., Inc. with the FDA for Akro-sil Foley Kit 30cc.
| Device ID | K771650 |
| 510k Number | K771650 |
| Device Name: | AKRO-SIL FOLEY KIT 30CC |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | LATEX IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-29 |
| Decision Date | 1977-09-20 |