The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Needle Range (general Hospital).
Device ID | K811966 |
510k Number | K811966 |
Device Name: | VISITEC NEEDLE RANGE (GENERAL HOSPITAL) |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | VISITEC CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-10 |
Decision Date | 1981-07-23 |