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 |