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 |