The following data is part of a premarket notification filed by Spelna, Inc. with the FDA for Satlec Prophy Unit Pu 3055.
| Device ID | K852521 |
| 510k Number | K852521 |
| Device Name: | SATLEC PROPHY UNIT PU 3055 |
| Classification | Airbrush |
| Applicant | SPELNA, INC. P.O. BOX 3395 Fredericksburg, VA 22402 |
| Contact | Robert E Mcdonnell |
| Correspondent | Robert E Mcdonnell SPELNA, INC. P.O. BOX 3395 Fredericksburg, VA 22402 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-14 |
| Decision Date | 1985-07-31 |