The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Dental Implant Custom Surgical Pack.
Device ID | K922650 |
510k Number | K922650 |
Device Name: | ACE DENTAL IMPLANT CUSTOM SURGICAL PACK |
Classification | Unit, Operative Dental |
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 | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-03 |
Decision Date | 1994-01-10 |