The following data is part of a premarket notification filed by Edward Manougian, M.d. with the FDA for Act, Suction Tip.
Device ID | K842779 |
510k Number | K842779 |
Device Name: | ACT, SUCTION TIP |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | EDWARD MANOUGIAN, M.D. 1517 SUMMIT ROAD Berkeley, CA 94708 - |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-16 |
Decision Date | 1984-10-12 |