The following data is part of a premarket notification filed by Tingle X-ray Products, Inc. with the FDA for Bc/wt/pf.
Device ID | K930249 |
510k Number | K930249 |
Device Name: | BC/WT/PF |
Classification | Holder, Radiographic Cassette, Wall-mounted |
Applicant | TINGLE X-RAY PRODUCTS, INC. 10629 TXR RD. Vance, AL 35490 |
Contact | Jerry M Tingle |
Correspondent | Jerry M Tingle TINGLE X-RAY PRODUCTS, INC. 10629 TXR RD. Vance, AL 35490 |
Product Code | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-19 |
Decision Date | 1993-04-27 |