The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Custom Surgical Pack.
| Device ID | K922648 |
| 510k Number | K922648 |
| Device Name: | ACE CUSTOM SURGICAL PACK |
| Classification | General Surgery Tray |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Contact | Joao R Quintino |
| Correspondent | Joao R Quintino ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1993-03-20 |