The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Safe Lock Titanium Adapter Set.
| Device ID | K822550 |
| 510k Number | K822550 |
| Device Name: | SAFE LOCK TITANIUM ADAPTER SET |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861100705 | K822550 | 000 |
| 10840861100689 | K822550 | 000 |
| 10840861100672 | K822550 | 000 |