The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Isostatic Condenser.
| Device ID | K843901 |
| 510k Number | K843901 |
| Device Name: | ISOSTATIC CONDENSER |
| Classification | Condenser, Amalgam And Foil, Operative |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Robert Mandler |
| Correspondent | Robert Mandler SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Product Code | EKG |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-03 |
| Decision Date | 1984-12-03 |