The following data is part of a premarket notification filed by Arnell, Inc. with the FDA for Rabinowitz Gum Massager.
| Device ID | K862635 |
| 510k Number | K862635 |
| Device Name: | RABINOWITZ GUM MASSAGER |
| Classification | Tip, Rubber, Oral Hygiene |
| Applicant | ARNELL, INC. 7016 N. 57TH AVE. Glendale, AZ 85301 |
| Contact | Lewis Rabinowitz |
| Correspondent | Lewis Rabinowitz ARNELL, INC. 7016 N. 57TH AVE. Glendale, AZ 85301 |
| Product Code | JEW |
| CFR Regulation Number | 872.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-10 |
| Decision Date | 1986-09-25 |