The following data is part of a premarket notification filed by Pain Prevention Laboratory, Inc. with the FDA for Comfort Machine For Desensitization/anesthesia Use.
| Device ID | K873605 |
| 510k Number | K873605 |
| Device Name: | COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE |
| Classification | Device, Electrical Dental Anesthesia |
| Applicant | PAIN PREVENTION LABORATORY, INC. 3400 DUNDEE RD. NORTHBROOK, IL 60062 |
| Contact | JESS HALPERN |
| Correspondent | JESS HALPERN PAIN PREVENTION LABORATORY, INC. 3400 DUNDEE RD. NORTHBROOK, IL 60062 |
| Product Code | LWM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-04 |
| Decision Date | 1987-12-30 |