The following data is part of a premarket notification filed by Newport Bio Systems with the FDA for Newport Media Transfer Container.
Device ID | K852532 |
510k Number | K852532 |
Device Name: | NEWPORT MEDIA TRANSFER CONTAINER |
Classification | Flask, Tissue Culture |
Applicant | NEWPORT BIO SYSTEMS 1580 E. EDINGER AVE., STE C SANTA ANA, CA 92705 |
Contact | ROD ROBERT |
Correspondent | ROD ROBERT NEWPORT BIO SYSTEMS 1580 E. EDINGER AVE., STE C SANTA ANA, CA 92705 |
Product Code | KJA |
CFR Regulation Number | 864.2240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-14 |
Decision Date | 1985-08-22 |