The following data is part of a premarket notification filed by Seamless Hospital Products Co. with the FDA for Iv Start Tray.
Device ID | K820490 |
510k Number | K820490 |
Device Name: | IV START TRAY |
Classification | I.v. Start Kit |
Applicant | SEAMLESS HOSPITAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LRS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-23 |
Decision Date | 1982-03-16 |