The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace-dupont Composite Rings.
| Device ID | K955388 |
| 510k Number | K955388 |
| Device Name: | ACE-DUPONT COMPOSITE RINGS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen ACE MEDICAL CO. 2260 EAST EL SEGUNDO BLVD. Los Angeles, CA 90245 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-24 |
| Decision Date | 1996-01-31 |