The following data is part of a premarket notification filed by Bt Medical Co., Inc. with the FDA for Lead Apron.
Device ID | K931269 |
510k Number | K931269 |
Device Name: | LEAD APRON |
Classification | Apron, Leaded |
Applicant | BT MEDICAL CO., INC. SECOND AND DEPOT Bridgeport, PA 19405 |
Contact | Buckley Thompson |
Correspondent | Buckley Thompson BT MEDICAL CO., INC. SECOND AND DEPOT Bridgeport, PA 19405 |
Product Code | EAJ |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-08 |
Decision Date | 1993-06-02 |