The following data is part of a premarket notification filed by Corning Costar Corp. with the FDA for U - Star (micro-star).
Device ID | K860703 |
510k Number | K860703 |
Device Name: | U - STAR (MICRO-STAR) |
Classification | Set, I.v. Fluid Transfer |
Applicant | CORNING COSTAR CORP. 205 BROADWAY Cambridge, MA 02139 |
Contact | Peter C Sutcliffe |
Correspondent | Peter C Sutcliffe CORNING COSTAR CORP. 205 BROADWAY Cambridge, MA 02139 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-26 |
Decision Date | 1986-05-06 |