The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Dental Rubber Dam.
| Device ID | K923157 |
| 510k Number | K923157 |
| Device Name: | DENTAL RUBBER DAM |
| Classification | Dam, Rubber |
| Applicant | ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
| Contact | Glenn D Kazen |
| Correspondent | Glenn D Kazen ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1993-07-22 |