The following data is part of a premarket notification filed by Pain Prevention, Inc. with the FDA for Dental Anesthesia Apparatus.
| Device ID | K850425 |
| 510k Number | K850425 |
| Device Name: | DENTAL ANESTHESIA APPARATUS |
| Classification | Device, Muscle Monitoring |
| Applicant | PAIN PREVENTION, INC. 200 WEST MADISON ST. SUITE 3200 Chicago, IL 60606 |
| Contact | Richard D Harris |
| Correspondent | Richard D Harris PAIN PREVENTION, INC. 200 WEST MADISON ST. SUITE 3200 Chicago, IL 60606 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-04 |
| Decision Date | 1986-10-09 |