The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Ccpd Cycler Set W/5 Pronged Safe Lock.
| Device ID | K822549 |
| 510k Number | K822549 |
| Device Name: | CCPD CYCLER SET W/5 PRONGED SAFE LOCK |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
| Contact | Joseph J Butler |
| Correspondent | Joseph J Butler AMERICAN MEDICAL PRODUCTS, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-24 |
| Decision Date | 1982-10-13 |