The following data is part of a premarket notification filed by Scott Imaging Intl., Inc. with the FDA for Ntbs-1417, 1436, Tbs-1417.
Device ID | K946260 |
510k Number | K946260 |
Device Name: | NTBS-1417, 1436, TBS-1417 |
Classification | Holder, Radiographic Cassette, Wall-mounted |
Applicant | SCOTT IMAGING INTL., INC. 3510 COTTAGE HILL RD. Mobile, AL 36609 |
Contact | Michael W Scott |
Correspondent | Michael W Scott SCOTT IMAGING INTL., INC. 3510 COTTAGE HILL RD. Mobile, AL 36609 |
Product Code | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-13 |
Decision Date | 1995-03-31 |