The following data is part of a premarket notification filed by Zimmar Consulting Ltd. with the FDA for Pharma-plast Syringe.
Device ID | K843471 |
510k Number | K843471 |
Device Name: | PHARMA-PLAST SYRINGE |
Classification | Syringe, Piston |
Applicant | ZIMMAR CONSULTING LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Contact | Douglass M Bennett |
Correspondent | Douglass M Bennett ZIMMAR CONSULTING LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
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 |