The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Op-face Mask(masque De Chirugie).
Device ID | K851556 |
510k Number | K851556 |
Device Name: | OP-FACE MASK(MASQUE DE CHIRUGIE) |
Classification | Mask, Surgical |
Applicant | ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
Contact | Chambord |
Correspondent | Chambord ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-16 |
Decision Date | 1985-04-30 |