The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Spirit Ii And Spirit Treatment Center.
| Device ID | K946187 |
| 510k Number | K946187 |
| Device Name: | SPIRIT II AND SPIRIT TREATMENT CENTER |
| Classification | Unit, Operative Dental |
| Applicant | PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
| Contact | Kristi Kunkel |
| Correspondent | Kristi Kunkel PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-03-01 |