The following data is part of a premarket notification filed by Intl. Equipment And Supply Corp. with the FDA for Pds-2000.
| Device ID | K902653 |
| 510k Number | K902653 |
| Device Name: | PDS-2000 |
| Classification | Carver, Wax, Dental |
| Applicant | INTL. EQUIPMENT AND SUPPLY CORP. 3637 NORTH MERIDIAN ST. Indianapolis, IN 46208 |
| Contact | James R Bailey |
| Correspondent | James R Bailey INTL. EQUIPMENT AND SUPPLY CORP. 3637 NORTH MERIDIAN ST. Indianapolis, IN 46208 |
| Product Code | EIK |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-15 |
| Decision Date | 1990-09-13 |