The following data is part of a premarket notification filed by Bay Technical Products, Inc. with the FDA for Disposable Radiolucent Rubber Dam Clamp.
| Device ID | K915207 |
| 510k Number | K915207 |
| Device Name: | DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP |
| Classification | Clamp, Rubber Dam |
| Applicant | BAY TECHNICAL PRODUCTS, INC. 1895 MOWRY AVE., SUITE 110 Fremont, CA 94538 |
| Contact | Steven R Jacoby |
| Correspondent | Steven R Jacoby BAY TECHNICAL PRODUCTS, INC. 1895 MOWRY AVE., SUITE 110 Fremont, CA 94538 |
| Product Code | EEF |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1992-02-14 |