The following data is part of a premarket notification filed by Pacific Union Dental, Inc. with the FDA for Stainless Steel Den. Crown Remover & Ama./comp.car.
| Device ID | K863500 |
| 510k Number | K863500 |
| Device Name: | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR |
| Classification | Remover, Crown |
| Applicant | PACIFIC UNION DENTAL, INC. P.O. BOX 2025 Silver Spring, MD 20902 |
| Contact | Kenneth Woo |
| Correspondent | Kenneth Woo PACIFIC UNION DENTAL, INC. P.O. BOX 2025 Silver Spring, MD 20902 |
| Product Code | EIS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-09-22 |