The following data is part of a premarket notification filed by Dispomed, Inc. with the FDA for Dental Gown.
| Device ID | K891058 |
| 510k Number | K891058 |
| Device Name: | DENTAL GOWN |
| Classification | Gown, Surgical |
| Applicant | DISPOMED, INC. 1201 SOUTH FLOWER ST. Burbank, CA 91520 |
| Contact | Kent Braniff |
| Correspondent | Kent Braniff DISPOMED, INC. 1201 SOUTH FLOWER ST. Burbank, CA 91520 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-04-12 |