The following data is part of a premarket notification filed by Custom Pack Reliability with the FDA for Cpr Foley Cahteter Kit.
| Device ID | K960214 |
| 510k Number | K960214 |
| Device Name: | CPR FOLEY CAHTETER KIT |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando, FL 32811 |
| Contact | Richard L Ellwood |
| Correspondent | Richard L Ellwood CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando, FL 32811 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-04-01 |