The following data is part of a premarket notification filed by Zimmar Consulting Ltd. with the FDA for Pharma-plast Insulin Syringe.
Device ID | K843473 |
510k Number | K843473 |
Device Name: | PHARMA-PLAST INSULIN SYRINGE |
Classification | Syringe, Piston |
Applicant | ZIMMAR CONSULTING LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Douglass M Bennett |
Correspondent | Douglass M Bennett ZIMMAR CONSULTING LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-06 |
Decision Date | 1984-10-31 |