The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Rectilinear Scanner Model #187-270.
Device ID | K895799 |
510k Number | K895799 |
Device Name: | RECTILINEAR SCANNER MODEL #187-270 |
Classification | Scanner, Rectilinear, Nuclear |
Applicant | ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Contact | Clyde Schlein |
Correspondent | Clyde Schlein ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Product Code | IYW |
CFR Regulation Number | 892.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-28 |
Decision Date | 1990-02-01 |